Herbalife Diet While Pregnant
Nov 8, 2011 | By Theresa Rosenthal
During pregnancy, the average woman should consume about 2,500 calories a day instead of the approximately 2,100 calories necessary before pregnancy. Consumption of any health or supplement product during pregnancy should contribute to these caloric needs, rather than restrict them. Diet shakes in general may safely be consumed during pregnancy when taken as a snack and not a meal-replacement. Herbalife products have some health and financial concerns that should be taken into consideration, especially during your pregnancy. Please consult with your physician about what supplements are appropriate for your pregnancy diet.
Dieting While Pregnant
Herbalife produces many different products for various needs, though many people use the protein shakes for weight management or fitness goals. The most important thing to remember during your pregnancy is that dieting is not recommended. Extra calories are needed each day for your body and your developing baby. Restricting these calories could cause problems for you and your baby’s growth due to malnutrition. Diet products, such as Herbalife weight management supplements and protein shakes, are not prohibited during pregnancy unless you’re using them to diet, or relying on them every day for your nutritional needs. Please consult your physician before adding supplements to your pregnancy diet.
Herbalife While Pregnant
Herbalife offers an entire line of products to support weight management, digestive health, personal care, energy, fitness, immune system and heart health. Each product solution offers a variety of herbal formulas, beverages, shampoos and skin care. While you may opt for the protein shakes under the fitness category or a nutritional shake from the weight management product line, make sure you are using them only in addition to healthy meals, not as a replacement. Since there are several Herbalife products, each one should be considered separately for their respective ingredients. Remember to consult your physician before making supplemental changes to your pregnancy diet.
Herbalife Dangers
There may be potential dangers when
taking Herbalife products, which should be considered especially during
pregnancy. Between 1998 and 2004, 10 cases of liver toxicity caused by
Herbalife products were reported, as explained in the October 2007 issue
of "Journal of Hepatology." Another study published in
"Pharmacoepidemiology and Drug Safety" in July 2011 revealed 20 cases of
liver damage in 2003 leading to concerns about the liver safety of
Herbalife products. Such concerns should be taken into consideration in
regard to your pregnancy.
Cost of Herbalife
According to the Herbalife website, Herbalife is a multilevel marketing program and the products can only be purchased through independent distributors. Nextag.com compares the prices of products across the Internet and reveals the cost of Herbalife products to be fairly expensive. For example, two shake mix containers are $58. Depending on how often you will be consuming the products, this may be an expensive investment. While money may not be a concern to some pregnant mothers, others should take note that these expensive Herbalife products are not needed nor necessarily recommended for a healthy pregnancy.
References
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The Side Effects of a LiftOFF HERBALIFE Energy Drink
Ginseng
Ginseng can slow the aging process and improve thinking, according to a December 2009 review in the "Chinese Journal of Integrative Medicine." These benefits may come at a price as ginseng can also cause allergic reactions. A clinical trial described in the July 2004 edition of the "Annals of Medicine" discovered a potential drug interaction associated with ginseng use. Participants taking warfarin, a blood-thinning drug, also received ginseng for three weeks. Relative to baseline, ginseng significantly reduced the effectiveness of warfarin. This change could prove fatal in some cases.
References
Article reviewed by Tina Boyle Last updated on: Jun 30, 2011
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Sep 1, 2011 | By
Guarana
tea is made from the berries of the guarana plant, a bush native to the
Amazon river basin. Indigenous peoples of the Amazon rainforest have
used guarana as an herbal medicine to treat many ailments, including
headache. Like any health supplement, consult your doctor before taking
guarana.
Headache
Guarana may be an effective short-term treatment for headaches, according to the University of Colorado Denver College of Pharmacy. However, guarana is not recommended for treatment of chronic headache, and should not be taken for more than seven days in a row, in order to reduce the risk of side effects such as nausea, anxiety, irritability and increased heart rate.
Tea
Guarana tea is often made by dissolving powered guarana berries in hot water. For optimal results, combine a half to 1 tsp. of powdered guarana with 8 oz. of hot water, recommends CrazyForTea.com. Alternatively, purified guarana supplements can be taken, at a dose of 200 to 800 mg, reports A Nurse's Guide to Herbal Remedies.
Active Ingredient
The likely active ingredient in guarana tea responsible for the effect on headache is caffeine, explains the New York University Langone Medical Center. Although other related stimulants, including theobromine and theophylline, may also play a role. Caffeine is often an effective treatment for headaches for people who do not regularly consume caffeine, according to an article published in the May 2007 issue of the medical journal "Neurological Sciences."
Too Much Caffeine
While occasional consumption of caffeine, in guarana tea or other forms, may be beneficial for headaches, frequent consumption of guarana tea may actual result in more headaches, warns the article in "Neurological Sciences." Long-term consumption of caffeine can lead to physical dependence, which causes withdrawal in the absence of caffeine. One of the common symptoms of caffeine withdrawal is headache, sometimes chronic headaches.
ReferencesArticle reviewed by Tina Boyle Last updated on: Sep 1, 2011 | By Matthew Busse
The Moderator I hereby thank the legislators Miss Tian Qiujin 2011.08.12 in the Legislative Yuan generous attempts to help the victims of Herbalife held a press conference!
Image: Fu Fang Shuo / photo
(Please read the following three reports, victim statements and related laws and regulations continue reading)
Reported (a) the new head capsule Fu Fang Shuo / Taipei
The allergic When detox direct sales nutrition risk kill elderly man
Eat nutritious health food have to be careful! Surnamed Zhang old man eating son bought for his well-known health food "Herbalife" Unexpectedly, the symptoms of systemic redness peeling, dealers also argued that "detoxification" and told the old man to continue to eat, causing the elderly man peeling pus , memory loss, confusion, and nearly died. The man surnamed Zhang the son Zhang Bingshen today (12) morning, accompanied by DPP Legislator Tien Chiu pansy held a press conference, broadside dealer disregard for human life, requiring manufacturers to provide compensation. However, the scene of the senior manager of the the Herbalife Public Affairs Shih Yi-Ru Reason Law, Herbalife tenable, the two sides talking to no intersection.
Zhangbing Shen pointed out that more than seven years old, his father, filial heart, before buying a lot of high price of Herbalife nutritional supplements nutritional supplements. Unexpectedly, the father, after eating, the body begins to redness, itchy situation, asking different Distributor, expressed normal detoxification ", ZhangFu continued safe to eat. Subsequently led to the February 2009 to March 2010, Zhang parent total emergency 4 times, hospitalized six times, almost died of sepsis. The physicians highly suspected food allergy with Herbalife, stop eating, allergic condition immediately improved.
Zhang Bingshen broadside, Herbalife registered with the Department of Health Food Distributor has swindle called "health food", even "detox" efficacy, harm his father almost lost his life, and he suspected Herbalife with false advertising, deception Distributors and consumers, the end of the day, victimized consumers, fined Distributors Corporation was entirely responsible without warnings do not want to raise very unreasonable.
Yi-Ru Shi said, Herbalife clearly marked for each nutritional supplements are "food", and therefore do not need to carry a boxed warning. To the proceedings for this event can not be directly prove ZhangFu allergy symptoms Herbalife Food-related training courses for direct sales personnel requirements shall not claim to have medical benefits. But for the poor direct sales personnel, Herbalife can not be responsible. Herbalife to appoint lawyers also said that if any harm acts of goodwill, it will take action.
Zhang Bingshen stressed that he will get justice if the Herbalife think he deliberately hurt goodwill, "Welcome to the divisions", but if subsequently proved to be the responsibility of Herbalife. The two sides talk past each other in the press conference, there is no intersection.
Wang Huiying, food inspection chief of the Department of Health, said that after the incident, has all Herbalife products sent to the health unit of a comprehensive test, the tests meet the standards for exaggerated advertising section open penalty. She called on the people, nutritional supplements are not equal alternative to dinner, no efficacy and if unwell situation should immediately stop eating, and a doctor as soon as possible.
Reported (2) CNA He Mengkui / Taipei
Codex Alimentarius loophole legislators Yuxiu law
Democratic Progressive Party Legislator Tien Chiu pansy, said today that the citizens have told her petition severe allergic dietary supplement products, related industry should indicate the product ingredients may react, her proposal would amend the law to fill loopholes in the law.
Petition populace Mr. Zhang morning held a press conference in the field autumn pansy accompanied pointed out, the 73-year-old father after taking Herbalife nutritional supplement products, severe allergies, direct sales staff claimed detoxification reaction to his father continued to take the last almost caused sepsis.
Mr. Zhang stressed that his father is not the case, calling for all the victims out to prove, adding "Herbalife victims Union". He believes that Herbalife should carry a boxed warning on the product and training good first-line pharmaceutical salesman knowledge, do not ignore the lives and safety of consumers.
The indictment of Mr. Zhang, Shi Yi-Ru, the Herbalife Public Affairs Manager, Herbalife sell food instead of healthy food, in accordance with the laws and regulations of the Republic of China does not have a boxed warning, but HE Bao Fuji in the enterprise responsibility has a boxed warning on the product, and also requires the distributor can not be claimed that the product has the effect of efficacy or detoxification.
He countered, before the onset of his father, Herbalife and not food boxed warning, he reflects, Herbalife was boxed warning. He also criticized the Department of Health connivance Herbalife endangering the health of citizens, leaving it without human testing, the poison test the product, he decided to make the country lose the lawsuit.
Wang Huiying, section chief of the Department of Health, Food and Drug Administration said after receiving the case, the Department of Health (DH) has for the first time require health unit survey also investigated products advertising content, including raw materials and heavy metals testing, found to meet the health food-related laws and regulations, but exaggerate the efficacy. She called on the people not to believe the the puffery advertised effect, if there is not, we must seek medical treatment as soon as possible, otherwise the expensive and beverages.
TIAN Qiu Jin of Mr. Zhang Lao disabling symptoms disappeared after the Herbalife products, but Herbalife has nothing to do with the consumption of Herbalife also said that Mr. Chang symptoms, consumers are significantly disadvantaged, her proposal would amend the law to make up legal loopholes.
Reported (3) Epoch Shi Chi Yin / Taipei
Eat Herbalife allergenic mistakenly when the detoxification Desk old man insurance dead
Legislator Tien Chiu pansy accompanied the petition by Zhang Bingsheng the 12th held a press conference to point out that the father after taking Herbalife nutritional supplement products, severe allergies, and direct sales staff has said that a detoxification reaction to his father continued to take the last almost causing sepsis .
Zhang Bingsheng filial heart, before buying the high price of Herbalife nutritional supplements nutritional supplements. Unexpectedly, the father, after eating, the body begins to redness, itching, and even body peeling, edema, exudate situation, asking different distributor expressed normal detoxification ", the To ZhangFu continued safe to eat.
He said that his father during the taking total emergency 4 times, hospitalized six times, almost died. Stated on the certificate of the physician's diagnosis: allergies, suspected health food due to Staphylococcus aureus bacteremia. "The physician recommends disabling Herbalife products, allergic condition immediately improved.
He pointed out that Herbalife registered with the Department of Health Food Distributor has swindle called "health food", and even the efficacy of "detox".
To Shi Yi Ruqiang tune, Herbalife, Public Affairs Manager, Herbalife sold food health food, but based on corporate responsibility in a boxed warning on the product in accordance with the laws and regulations do not have to carry a boxed warning, In addition, to the proceedings for this event can not be direct proof sheets Father allergy symptoms with Herbalife food, also require the distributor can not be claimed that the product has the effect of efficacy or detoxification.
The Food and Drug Administration food group, food inspection the registration section chief Wang Huiying said, in this case occurred, has been Herbalife's products to send health units inspection, including the inspection of raw materials and heavy metals test compliant and abnormal. However, she said, Herbalife's advertising propaganda, really exaggerate the phenomenon open penalty for puffery and require improvements.
She also called on the people, and nutritional supplements are not equal alternative to dinner, and also do not have any efficacy, the body does not appear the case, should immediately stop eating, consult a doctor as soon as possible.
Finally, TIAN Qiu Jin of Mr. Chang disable Herbalife products after the symptoms disappear, the symptoms associated with the consumption of Herbalife, Herbalife's resolutely old gentleman's nothing to do, obviously disadvantaged consumers, her proposal would amend the law to make up for the loopholes in the law .
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(My father caused due to consumption of Herbalife 
Severe allergic reaction)
Painful experience, that ring
Victim statement:
My father is Herbalife victims press conference the parties, the facts of the case on behalf of my father statement is as follows:
1) court proceedings has not yet made a judgment of my father's illness has nothing to do with Herbalife, and we find that the judicial and medical personnel involved in the documented false or forged instrument is suspected, however, the case prosecutor not to prosecute is insufficient evidence. Therefore, I propose to committal for trial, to fight for the last axiom justice ditch, looking forward to the judicial officer ought to be based on the relevant medical diagnosis to confirm the causes of my father with a considerable degree of causality with Herbalife, and references the relevant administrative regulations to prosecute the company .
2) to my father to buy Herbalife products consumption sister, is not myself Zhang Bingsheng purchased. Sister joined Herbalife Distributors on the occasion, my father has also support 12 million to obtain the Distributor qualifications. This product can only be obtained from Herbalife Distributor, most direct marketers are the friends and family as a product of the object sharing, so my father will through the hands of the sister consumption of Herbalife, which is pass the direct selling industry norm man runs into trouble.
3) Herbalife representative of its own products are "food" rather than "health food" or "health food" as prevarication words of shirking its responsibility, but in accordance with the existing laws and norms, claiming to provide special nutrients and health benefits of the food, as the Health Food Control Act of objects.
The 4) Herbalife ingots food should be registered in accordance with the input gelcap like food inspection approved, rejected, principles and other regulations of the supplement to the application for inspection, but the Herbalife Company and Chief, Department of Health did not put forward the inspection audit nuclear provable.
5) The Chief, Department of Health (DH) has not proposed to send test of inspection Herbalife products are in line with the standard of the report proved empty rumor.
6) the position of the Chief, Department of Health and insights are similar with Herbalife, how can we expect the Department of Health, the Food and Drug Administration "due diligence to back the people's health and food safety checks? No wonder conscience physician bluntly critical of the establishment of the esophagus Bureau is simply a hoax!
7) We demand the HE HE Fu home claimed regular clinical experimental track "proved and approved by the Department of Health inspection to prove, to prove that the products are in line with the laws and regulations.
8) I also asked Herbalife written communications report to the head office of the United States proved to show my father victimization return, I am advised by the company at the beginning of the incident, my father was the victim of the case shall be sent to the U.S. company to do causality identification, I wait for the Corporation identification results. (My Herbalife company inform the U.S. company my father's case, doubt it!)
9) Please Herbalife produce product liability insurance contract content to us consumers to prove the performance guarantee of product safety, to maintain their own goodwill.
10) due to the Herbalife product liability and the production of the source of defective products are the U.S. company, so we really object of claims is also the source. If due compensation in the future, I will be the claimant the gold as social things needed to take care of my father, which was I set up the grounds and purposes of Herbalife victims League. I also call upon the people to join our ranks, and jointly safeguard the security and interests of its own and I have the same philosophy and goals.
Summing up the theory, Herbalife products are in clear violation of existing laws and norms, and the security of the product is unknown, however, the section chief of the Department of Health and Herbalife representative statement significant breach of professional conscience and morality. Shi Yi-Ru, the Herbalife Public Affairs Manager, said the company sold food, not health food, do not have to carry a boxed warning required, based on corporate responsibility, but the company has been filling in the product, and also requires the Distributor product efficacy can not be claimed, Herbalife company issued a statement, said the Prosecutor's Office of the High Court disposes of the book clearly old man surnamed Zhang cases can not be, directly or indirectly, to prove any association with Herbalife products ... however these exposition and unconvincing!! (Also, please see this blog post)
To appeal to Herbalife Distributors should uphold the moral conscience in direct sales, and medical personnel should uphold the ethics of conscience to treat the victims of suspected health food, because you are the first line of the face of the victims, an obligation and responsibility to appeal to the people and government together to prevent harm health food.
Relevant laws and regulations as follows:
(1) health food Q & A (Source: Executive Yuan Department of Health)
What is healthy food? Healthy food means as defined in the Health Food Control Act, the Department has Baojian effect to the labeling or advertising of food; aforementioned alleged health benefits that enough to advance public health or reduce disease risk of harm, and has scientific evidence to support the efficacy of The announcement by the Department of Health, rather than treatment, correction of human disease medicine effectiveness.
Product name without the words "health food", whether it is still healthy food management law? In addition to the product name should, depending on the product and the declared content. Food labeling or advertising content involving the health effects of the announcement by the Department of Health, and shall be subject to the norms of the Health Food Control Act. Other words, not to replace the product name: "health food", "functional food", "food nutrition", "organic food", "natural foods" or other similar names, you can circumvent the law of the management.
Health food inspection and registration should attach components, specifications and other information, by the audit is listed on the product packaging still have marked ingredient recipe? Health food approved after its commercially available product packaging labeling should comply with the sections of the project required by section 13 of the Health Food Control Act, which does not include the product's ingredient recipe, but its contents content marked descending order and marked nutrients and content, mark the way and content should be consistent with the Department of Health, and detailed provisions went ahead to the Department of Health website (www.doh.gov.tw) query.
(2) health food and health food management (Source: Department of Health Food Hygiene Department)
In capsule form, tablet form of food because of its appearance, is easy to be confused with the drugs, the former according to the Bureau of Foreign Trade of the Ministry of Economic Affairs, 1989 announcement tablet form, capsule form of general food should be handled nuclear prepare a letter with the Department of Health input visa " regulations, the industry has long according to their input tablet form needs to be presented to the Department of Health, capsule-shaped food applications for nuclear preparedness; council after the announcement in 1994, restrict the importation of goods, the commission check input Consolidated List of Commodities "in with Ming Syria, the two class appearance of the food should be the Department of Health to apply for the issuance of a license file, so that Lihai relations with the file handle matters input checking.
(3) "domestic vitamin tablets, capsules food inspection and registration of" Q & A (Source: Department of Health, the Food and Drug Administration)
(1) Prior to the Listing, which food must first go through the inspection of registration to the Department of Health or license? Enter the tablet form capsules food "," single product (unilateral) food additives (spices except), special nutritional food, genetically modified food inspection and registration must apply in accordance with the provisions of Article 14 of the Act Governing Food Sanitation announcement food "and" domestic vitamin tablet form capsules food. ......
(4) Inspection of Food Imports Measures (Source: Executive Yuan Department of Health)
Application for inspection of products is one of the following circumstances, adopted by batch inspection, and shall submit the test report, inspection authorities may perform inspection: in accordance with domestic and international product safety information or scientific evidence of significant harm to the human body. ......
(5) Summary of Conclusion (Source: Executive Yuan Department of Health)
... In summary, from a regulatory point of view of some basic concepts can skip summarized as follows:
Food can be divided into general food and health food. "Health food" is just a term of general food is a common noun; "health food" is a proper noun, legal terms, permit registered for healthy food, in order to call it.
The main difference in health food and health food (usually food), health food demands of the specific health benefits, general food shall be prohibited.
All food do not exaggerate, hypocrisy, or concerning the efficacy of the labeling or advertising. The general food of breaches to the Act Governing Food Sanitation Office, involving "health food" and "health benefits" (by the EPA announcement is the limit), then the Health Food Control Act at the Office. Healthy food is designed to apply to the Health Food Control Act.
4. General food in addition to the part have been announced must apply for registration by examination, most do not need registration; health food registration prior permission to enter or production.
Life that should be wasted on the good things, but wasted you see the groom's part of life in the above dogma Declaration, I pitch are ashamed, but still want the general public to have the right of health food and food products in general, the basic concept . Another For one, certified health food has some health benefits, but also the day-to-day care only to receive better health and reduce disease risk function, rather than alternative medicine for the treatment, correction of disease with the body once ailments still should first seek the proper medical channels, do not listen to exaggerate the publicity, or the delay in medical treatment and damage to the body, then the non-healthy food intention.
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Liver International
Early View (Articles online in advance of print)
Felix Stickel 1, Kerstin Kessebohm 2, Rosemarie Weimann 3, Helmut K. Seitz 4
Article first published online: 11 JAN 2011
DOI: 10.1111/j.1478-3231.2010.02439.x
© 2011 John Wiley & Sons A/S
Author Information
1 Department of Visceral Surgery and Medicine, Institute of Clinical Pharmacology and Visceral Research, Inselspital, University of Berne, Berne, Switzerland
2 Institute of Clinical Pharmacology and Visceral Research, University of Berne, Berne, Switzerland
3 Institute of Pathology, University of Berne, Berne, Switzerland
4 Department of Medicine, Center of Alcohol Research, Liver Disease and Nutrition, Salem Medical Center, University of Heidelberg, Heidelberg, Germany
* Correspondence: Correspondence Felix Stickel, MD, Department of Visceral Surgery and Medicine, Institute of Clinical Pharmacology and Visceral Research, Inselspital, University of Bern, Murtenstr. 35, 3010 Bern, Switzerland Tel: +41 31 632 87 28 Fax: +41 31 632 49 97 e-mail: felix.stickel@ikp.unibe.ch
Keywords:
anabolic steroids; Camellia sinensis; cholestasis; hepatitis; retinoid toxicity; toxic liver injury
Abstract
Dietary supplements (DS) are easily available and increasingly used, and adverse hepatic reactions have been reported following their intake. To critically review the literature on liver injury because of DSs, delineating patterns and mechanisms of injury and to increase the awareness towards this cause of acute and chronic liver damage. Studies and case reports on liver injury specifically because of DSs published between 1990 and 2010 were searched in the PubMed and EMBASE data bases using the terms ‘dietary/nutritional supplements’, ‘adverse hepatic reactions’, ‘liver injury’; ‘hepatitis’, ‘liver failure’, ‘vitamin A’ and ‘retinoids’, and reviewed for yet unidentified publications. Significant liver injury was reported after intake of Herbalife® and Hydroxycut products, tea extracts from Camellia sinensis, products containing usnic acid and high contents of vitamin A, anabolic steroids and others. No uniform pattern of hepatotoxicity has been identified and severity may range from asymptomatic elevations of serum liver enzymes to hepatic failure and death. Exact estimates on how frequent adverse hepatic reactions occur as a result of DSs cannot be provided. Liver injury from DSs mimicking other liver diseases is increasingly recognized. Measures to reduce risk include tighter regulation of their production and distribution and increased awareness of users and professionals of the potential risks.
Abbreviations
ALF, acute liver failure; DILI, drug-induced liver injury; DS, dietary supplements; FDA, Food and Drug Administration; HSC/MFB, hepatic stellate cells/portal myofibroblasts
The use of dietary supplements (DS) containing vitamins, anti-oxidants, fibre, trace elements, proteins, amino acids and herbal constituents has become a major health trend in affluent societies (1, 2). Consumption of DS in the USA has doubled to 18.9% of adults admitting their use only between 1999 and 2004 (3, 4); some investigations report their consumption up to 47% in certain subgroups such as among elder, non-smoking females with higher education (5). The rising popularity of DS is probably because of an increased awareness of consumers towards health in general and the desire to prevent diseases by an optimized nutritional status, and the persuasion that these treatments are safe (1, 2, 5, 6). Further, DS do not require prescriptions from health professionals allowing largely unrestricted access to relatively cheap products. Consequently, marketing such products has become a multibillion business largely unregulated by official health authorities (6–8).
In the USA, DS are expected to meet the standards outlined in the Dietary Supplement and Health Education Act published in 1994, which allows distribution without prior approval of their efficacy and safety by the Food and Drug Administration (FDA) (9). This simplified licensing practice does not ensure efficacy and safety in the same strict way as with the approval of conventional medications and treatments. Similarly, the European Union has set forth legislative measures for the distribution and marketing of DS and functional foods that are outlined in the European Commission 2000 White Paper on Food Safety (10, 11). This set of legislation pays tribute to the fact that DS may harbour specific problems because of their complex composition, particularly with respect to quality aspects, and defines guidelines for conducting premarketing in vitro and in vivo studies.
While adverse hepatic reactions from xenobiotics are well documented by pre- and post-marketing pharmacovigilance, the situation for DS is less well depicted as widespread and uncontrolled use and under-reporting prevent the determination of their true incidence. Additionally, a low awareness of users and providers towards their potential harms impedes their recognition as the causative agent in incidents of hepatotoxicity. Consequently, estimates of the frequency of DS-associated hepatic injury are likely imprecise and, possibly, too low. The proportion of hepatotoxicity ascribed to DS varies from 2% in a Spanish study (12) describing 531 cases of drug-induced liver injury (DILI) to approximately 10% in a series from the US Drug-Induced Liver Injury Network (DILIN) (13). Figures were as high as 35% in a small series of 20 patients developing acute liver failure with DS exposure as the only identifiable cause of liver damage (14).
Our article aimed to review and describe the literature on liver injury because of DS, delineate patterns and mechanisms of injury and to increase the awareness towards this possible cause of acute and chronic liver damage.
Literature search methodology
In February 2010, case reports and series thereof on liver injury specifically occurring following the consumption of DS published between 1990 and 2010 were searched in PubMed and EMBASE data bases using the terms ‘adverse hepatic reactions’, ‘anabolic steroids’, ‘Camellia sinensis’, ‘dietary/nutritional supplements’, ‘Herbalife’, ‘hepatitis’, ‘Hydroxycut’, ‘green tea’, ‘liver failure’, ‘liver injury’, ‘Noni’, ‘retinoids’, ‘vitamin A’ and critically reviewed. Retrieved publications were searched for yet unidentified publications. Remedies were considered DS if consumed as an aid to improve nutritional status, to loose weight or to treat constipation. Cases of liver injury from preparations taken for other causes than nutritional purposes were not included. No language restriction was used.
While hepatotoxicity from herbal medicines in general has been addressed
in several reviews (15–18), summaries specifically devoted to
liver-related risks along with DS are scarce (19). In the following, a
panel of rather distinct DS preparations associated with liver injury
are described (
Table 1).
Specific dietary supplements associated with liver injury
Herbalife® (Los Angeles, CA, USA) sells nutritional and herbal supplements as tablets, capsules, drinks and energy bars for weight control, improvement of nutrition, ‘well-being’ and cosmetics. In 2006, the stock market quoted that Herbalife® company had a revenue of US$3.1 billion via online marketing or through independently operating sales agents.
There are so far six published reports on liver damage following the intake of Herbalife® products since 2007 describing 34 cases from five countries (Switzerland, Israel, Spain, Argentina and Iceland), although Herbalife® products are sold in at least 60 countries worldwide (20–25). Individual data of all reports are displayed in Table 2. Pattern of injury was mostly hepatocellular, but mixed and cholestatic enzyme patterns were also observed. Severity ranged from mild to severe hepatic damage including cirrhosis and acute liver failure requiring liver transplantation, which was successful in one patient while the second died because of post-operative complications. Causality between intake of Herbalife® products and the evolution of liver injury was assessed by widely used scores (26, 27) in five of the six reports and considered ‘certain’ in at least five patients by a positive rechallenge reaction and ‘probable’ in the majority of the remaining cases (20, 21).
Camellia sinensis (green tea)
Green tea is among the most frequently consumed drinks in the USA and often used as a DS. The first report on liver injury following the ingestion of green tea extracts and preparations thereof was published in 1999 (31), and since then, numerous consecutive cases were reported to regulatory agencies worldwide. With effect of April 2003, the manufacturer of Exolise® (Arkopharma, Carros, France), a hydro-alcoholic extract of C. sinensis, has revocated all of their products after altogether 13 cases of acute liver damage following its intake were reported to the French pharmacovigilance authorities (Agence Francaise de Securité Sanitaire de Produits de Sanité; http://www.afssaps.sante.fr/). As a reaction to these accumulating reports, the US Pharmacopeia performed a systematic review of all cases accessible from PubMed, EMBASE and pharmacovigilance data bases in the USA, Canada, UK and Australia reporting on 34 single cases of liver injury following the ingestion of numerous different green tea preparations (32). Herein, case reports were retrospectively evaluated according to the Naranjo causality algorithm scale (33), and 27 reports pertaining to liver damage were labelled as ‘possibly’ and the remaining seven cases as ‘probably’ linked to green tea. Another Medline search review of cases on green tea liver injury from the same year also retrieved 34 published reports and described two further yet unpublished cases (34). On histological examination, livers of patients revealed inflammatory reactions, cholestasis, occasionally steatosis and necrosis. Although there was some overlap of single reports between these two review articles, collected case reports were not identical and jointly provided details on 58 cases of hepatotoxicity along with the intake of green tea extracts, powdered leaves, green tea infusions and hydro-alcoholic and aqueous extracts. In Mazzanti's summary, no causality re-evaluation was performed, but information on de- and rechallenge is provided for every case indicating a positive rechallenge response with accelerated recurrence of liver injury in seven of 36 incidents, which strongly suggests a causal relationship between the observed liver injury and green tea consumption. Of concern is that there was one reported death. However, a note of caution is warranted in many of the cases regarding an exclusive assignment of causality to green tea, because many patients who experienced adverse hepatic reactions also took numerous other products with a published record of hepatotoxicity, such as Cassia angustifolia, Hydroxycut and Ephedra sinica (for all three, please see below). Since these two review articles, additional cases have been published from Belgium reporting on a 42-year-old female patient who developed cholestatic hepatitis 6 months after starting Densitive® (Kerastase Nutritients, L'Oréal, Paris), which contains C. sinensis (35). Upon dechallenge, a full recovery was recorded. Other causes of liver injury were carefully excluded, but formal causality assessment using an established score was not performed. In the second case, jaundice, weight loss and subacute hepatitis developed in a 76-year-old man who regularly drank green tea infusions (36). Histology showed marked necro-inflammation, and transiently elevated antismooth muscle auto-antibodies were suggestive of autoimmunity induced by green tea constituents.
The mode of toxicity derived from green tea still remains incompletely understood but could be because of (−)-epigallocatechin gallate or its metabolite (−)-epicatechin gallate, which, under certain conditions such as fasting, can induce oxidative stress-related liver damage (37). Interestingly, in vitro and in vivo experimental studies have demonstrated both hepatoprotective as well as hepatotoxic properties (37–40). Along this line, support for potentially hepatoprotective activity from green tea extracts comes from clinical studies studying its therapeutic effects in humans with liver diseases including liver cancer, cirrhosis and steatosis. Four randomized-controlled clinical trials, two cohort, one case–control and three cross-sectional studies from China, Japan and the USA were recently subjected to a systematic review and found overall favourable effects from green tea as reflected by reduced mortality, attenuated steatosis and reduced incidence of primary liver cancer (41).
Whether the risks from green tea consumption outweigh their benefits remains open, but current evidence as outlined above suggests a causal relationship between intake of green tea-containing products and hepatotoxicity. Consequently, in their systematic review, the US Pharmacopeia included a cautionary statement on green tea indicating this possibility (32).
Usnic acid
Some years ago, several cases of acute liver failure requiring liver transplantation following the intake of LipoKinetix®, a product extracted from lichens and fungi and sold as DS capsules, were reported (42–45). Onset of liver injury was usually acute with a maximum latency of 3 months and the injury pattern hepatocellular with massive elevations of ALT and AST. Lipokinetix contained usnic acid and was marketed as a weight-loss remedy. Efficacy for this indication was postulated based on its function as an uncoupler of the respiratory chain, which in principle can augment weight loss (46). Apart from usnic acid, LipoKinetix® contained norephedrine hydrochloride, diiodothyronine, yohimbine hydrochloride and caffeine, which were confirmed by analysing the used LipoKinetix® lots. None of the ingredients were associated previously with liver damage and inadvertent contamination was excluded. These serious events caused the withdrawal of LipoKinetix® from the market.
Hydroxycut
Only recently, several Hydroxycut products were retracted by the manufacturer following a warning posted by the FDA in May 2009 because of 23 reports of liver injury including cases with acute hepatic failure and subsequent liver transplantation (47–49). Hydroxycut preparations were sold as powder, capsules and tablets by conventional retailers, through Internet sources and via direct television marketing. Hydroxycut was used to support weight loss and by body builders. The manufacturer had been charged previously with several lawsuits for unfounded health claims. Before May 2009, its primary ingredients included Garcinia cambogia, Gymnema sylvestre, chromium polynicotinate, caffeine and green tea. Published cases were recently reviewed and showed acute onset after several weeks of intake with high levels of serum aminotransferases in the majority of cases, while others presented with a more insidious, usually cholestatic course (50).
Miscellaneous
Various other DS have been associated with acute and subacute liver damage such as Senna (C. angustifolia), which is used as a powder, tea or suppository to treat constipation. According to our search, a total of five reports with altogether five individual cases describe the evolution of variable liver pathologies including acute cytolytic hepatitis, subacute cholestatic hepatitis, acute liver failure and portal vein thrombosis upon consumption of Senna products (51–55). In some reports, Senna preparations were self-made or ingested excessively such as in a young woman taking approximately 10 times the recommended dose who developed cytolytic hepatitis, which completely subsided after stopping Senna (51). The causal relationship between the preparation and hepatitis was confirmed through a positive rechallenge in two cases (51, 52). Senna is biotransformed via intestinal bacteria to rhein anthrone, which is highly reactive and requires binding to glucuronide and sulphate via phase I oxidation for renal excretion (56). Rhein anthrone is suspected to function as an uncoupler of the respiratory chain, and can therefore possibly affect hepatocyte integrity under certain circumstances, such as in genetically predisposed individuals. Seybold et al. (52) describe a case of increased toxicity of Senna tea in a homozygous carrier of a genetic cytochrome P450 2D6 variant rendering the individual a poor metabolizer for phase I hepatic detoxification reactions.
Noni juice (Morinda citrifolia) has become increasingly popular in Western countries as a health tonic. Consumption of Noni was the presumed cause of acute hepatitis in a 45-year-old man who drank a glass of this tropical fruit over several weeks for preventive reasons and for ‘strengthening the immune system’ (57). Other possible aetiologies of acute hepatitis were ruled out and liver tests rapidly turned normal after the cessation of Noni intake. Since this first report in 2005, five additional cases have been published from Austria, Germany and Spain (58–61). Remarkably, two patients experienced liver failure of which one required liver transplantation. The pattern of liver injury was hepatocellular in all cases and occurred rapidly within a few weeks of exposure. Causality was formally assessed in two publications, but not considered ‘certain’ in any of the cases because no rechallenge was used. Also, at least two of totally six patients had concomitant medication with known hepatotoxic potential, such as interferon-β (62) and a Chinese herbal mixture (63) respectively. Responsibility of Noni preparations as the cause of liver injury in these cases is challenged by one of the manufacturers of Noni products (64, 65) by demonstrating experimental evidence of no dose-dependent hepatotoxicity and even hepatoprotective properties in some animal models of chronic liver injury (66, 67). However, a lack of dose-dependent hepatotoxicity does not exclude idiosyncratic drug toxicity, e.g. by inducing autoimmune reaction as shown by Yuce et al. (59) who found excessively high liver–kidney microsomal antibodies of 1:3840 in a patient drinking Noni juice for 4 weeks. Nevertheless, the true underlying pathophysiology of Noni-associated liver injury remains elusive because active components within Noni extracts such as flavonoids, glycosides, vitamins, anthraquinones and polyunsaturated fatty acids are not known to be hepatotoxic.
Chinese herbs have become highly popular among consumers in Western countries because of a prevailing belief in their efficacy and safety. Among many others, Ma huang (E. sinica) is marketed in the USA as a nasal decongestant and bronchodilator, and more recently as a weight-loss remedy. The first report of Ma huang-associated liver injury was about a woman developing acute hepatitis together with elevated antinuclear antibodies (ANA) and smooth muscle antibodies (SMA) after only 3 weeks of intake of Ma huang, but liver abnormalities resolved after its discontinuation (68). Another report suggested that intake of Ma huang was the cause of acute liver failure in a 58-year-old patient initiating her listing for high-urgency liver transplantation who also presented with elevated titres of SMA (69). Another report suggested an association of Ma huang-related liver injury with compound heterozygosity for the C282Y and H63D mutation in the haemochromatosis gene, proposing that excess hepatic iron could aggravate hepatotoxicity, possibly via enhancing oxidative stress (70). The largest series on severe liver injury because of the intake of Ma huang by Neff et al. (71) describes 10 cases of acute cytolytic hepatitis of which two subjects required liver transplantation and one died, while the remaining seven patients recovered spontaneously. These cases of severe liver damage and others referring to cardiac toxicity have prompted a warning by the FDA for the use of Epedra-containing DS such as Ma huang (72).
In 1986, Germander (Teucrium chamaedrys) was approved as a drug for the supportive treatment of obesity in France. Its subsequent widespread use precipitated numerous reports on acute, chronic and even fulminant hepatitis to the French pharmacovigilance authorities in 1992 (73–75). Within a median of 2 months, intake of daily doses between 600 and 1600 mg/day precipitated acute cytolytic hepatitis or chronic hepatitis with fibrosis and even cirrhosis (74, 76). All patients recovered after the discontinuation of treatment, but some relapsed under re-exposure. Germander contains saponins, glycosides, flavonoids and neoclerodane diterpenoids, which were shown to be converted into diterpenoid toxic metabolites by cytochrome P450 3A in mice (77). In conditions of glutathione depletion – such as during fasting – or after induction of cytochrome P450 3A, toxic diterpenoids are potent inducers of hepatocyte apoptosis (78, 79). Hence, in 1992, the license for Germander-containing products was withdrawn.
‘Onshidou-Genbi-Kounou’, another herbal marketed for weight loss, seemed the likely cause of chronic hepatitis in a 52-year-old Japanese woman who took this preparation for 2 months (80). Serum levels of liver enzymes were elevated to >1500 IU/l and ANA were positive with 1:160. All other possible causes for chronic hepatitis were excluded, and liver histology was compatible with drug-induced autoimmune hepatitis. The patient recovered completely without intervention on cessation of ‘Onshidou-Genbi-Kounou’ intake. In a larger series from Japan describing 12 patients with acute hepatitis after taking ‘Onshidou-Genbi-Kounou’ and ‘Chaso’ for weight loss, two patients developed liver failure of which one survived after successful liver transplantation and the other one died (81). ‘Onshidou-Genbi-Kounou’ contains several natural compounds (amachazuru, tea leaf, barbaloin, total saponin and polyphenols) and N-nitroso-fenfluramine. The latter demonstrated induction of mitochondrial permeability transition and hepatocyte apoptosis following uncoupling of oxidative phosphorylation and intracellular ATP depletion (82, 83).
Vitamin A-associated liver injury
DS fortified with vitamin A are used to prevent night blindness, to increase immune function and to promote health in general. Liver injury related to hypervitaminosis A is well known for many decades and comprises mild elevations of serum liver enzymes, cholestatic hepatitis, non-cirrhotic portal hypertension, progressive fibrosis and cirrhosis (84–87). Toxicity does not usually occur with standard doses below 50 000 IU/day as contained in common multivitamin preparations, but individual tolerability may vary (88). Pre-existing liver lesions including steatosis, chronic alcohol consumption, comedication with other potentially hepatotoxic drugs and young age may predispose certain individuals to develop vitamin A hepatotoxicity (89, 90). Several case reports have demonstrated significant hepatotoxicity with vitamin A doses as low as 20 000 IU/day (91), and upper limits of tolerability may even be lower in regular alcohol consumers (92).
Toxicity is mediated to the dose-dependent effect of retinoids on hepatic stellate cells/portal myofibroblasts (HSC/MFB), which are the key effector cells in the evolution of fibrosis and cirrhosis (93). Upon excessive vitamin A exposure, HSC/MFB start to produce collagens, downregulate collagenase activity and acquire the ability of contraction leading to elevation of blood pressure in the portal vein. In addition to this direct impact on HSC/MFB function and activity, retinoids can be transformed into metabolites that affect mitochondrial function and hepatocyte viability with resulting liver cell apoptosis (94, 95). This was shown to occur particularly when co-administered with alcohol. Dan and colleagues showed that retinoids can be transformed via alcohol-induced cytochrome P450 2E1 into highly reactive and toxic polar metabolites, which cause hepatocyte apoptosis upon caspase 3 activation (Fig. 2). Hence, health professionals should consult users carefully about the potential dangers of vitamin A, particularly when intended for longer period, in children and regular alcohol consumers.
Anabolic steroids
Anabolic steroids are an integral part of the nutritional concept of many athletes to improve fitness, muscle gain and exercise performance. Their use is widespread although anabolics are classified as class III substances and therefore subdued to strict rules (96). However, access via inofficial and sometimes illegal sources is easy, and therefore, in spite of tight rules, further adverse hepatic reactions following the consumption of anabolic steroids can be expected. Hepatotoxicity has been frequently described and patterns of injury delineated. Liver lesions include intrahepatic cholestasis, hepatitis, adenoma and hepatocellular carcinoma and rare malformations such as peliosis hepatis, a rare pathological entity characterized by the gross appearance of multiple cyst-like, blood-filled cavities within the liver (97, 98). A recent case series demonstrated the evolution of cholestasis 2 weeks after the intake of anabolic steroids had been stopped. All patients recovered fully after intake had been terminated (99). Even more worrisome is the observation that some DS may contain anabolic steroids sufficient to precipitate liver injury, as demonstrated by a recent case report showing cholestasis in two young men who took DS to enhance their body-building performance (100). Another case presented with a less favourable course as prolonged intrahepatic cholestasis and subsequent kidney failure developed (101). The precise mechanism underlying toxicity is yet unclear, but experimental data indicate direct hepatocellular toxicity from steroids via increased oxidative stress and subsequent impairment of function of the canalicular bile salt export pump (100).
A recent case–control study from Brazil suggested that anabolic steroids could be a cause of toxicant-associated non-alcoholic fatty liver disease (TAFLD) by comparing 95 recreational body builders using anabolic steroids with 85 non-users. In those consuming anabolic steroids, 12.6% of subjects revealed criteria compatible with TAFLD such as steatosis on ultrasound imaging, elevated serum transaminases and exclusion of relevant alcohol intake or concomitant medication, but no overweight or insulin resistance suggestive of metabolic NAFLD. In turn, 2.4% of body builders not using anabolic steroids showed clinical signs and findings suggestive of NAFLD. The authors concluded that the intake of anabolic steroids could be a cause of non-metabolic, but toxicant-associated NAFLD (102).
Conclusion
Hepatic injury secondary to consumption of DS is recognized, although its exact frequency remains unclear, mostly because evidence relies exclusively on case reports. Lack of stringent diagnostic criteria, poor awareness of consumers and prescribers, easy and uncontrolled access and under-reporting account for this epidemiological gap of knowledge. Diagnostic assessment of DS-associated should be made more consistent, and customized specifically to DS. Although causality categories reached in many of the published reports suggest a causal relationship between liver injury and the intake of certain DS products, pitfalls exist related to the used diagnostic scales, which have all been criticized for variable reasons and of which none is unequivocally accepted as being suitable for the evaluation of DS as a cause of liver injury. While the WHO score is not specifically designed to evaluate DILI (103), the Naranjo adverse drug reaction probability scale (33) was recently found to have low sensitivity (54%), poor negative predictive value (29%) and to lack reproducibility in a large series of cases of suspected hepatotoxicity (104) when compared with the Roussel Uclaf Causality Assessment Method (RUCAM) (26, 105). A clinical diagnostic scale has been suggested as a simple tool to assess adverse hepatic drug reactions and showed good correlation with RUCAM in one study (106), but not in another (107). To conclude, all used scores reveal merits and limitations, but a common consensus on which one is the best to apply in causality assessment of DS-associated liver damage has never been reached. In an approach to compensate for this lack of common agreement, recently, the DILIN was established to advance our understanding and research into DILI by initiating a prospective registry of patients with DILI for future studies into host clinical, genetic, environmental and immunological risk factors, and to develop standardized nomenclature, terminology and causality assessment instruments (108). Patients with liver injury because of herbal products are also eligible to be included. Herein, a causality score ranging from 1 (definite) to 5 (unlikely) as well as a severity score ranging from 1 (mild) to 5 (fatal) is applied by three hepatologists of the DILIN study group, thereby minimizing individual biases. In addition to accounting for the input of the reporting investigator who took the history, performed the physical examination and supervised the data collection, a prospective evaluation of other potential causes of liver injury and serial laboratory data through at least 6 months of follow-up are offered. However, the DILIN expert opinion is limited by its lack of generalizability and a low level of agreement between the three hepatologists (109). Hence, a certain degree of inaccuracy in assigning causality remains until better diagnostic measures are established.
Apart from diagnostic measures, better regulatory measures to assure safety and timely recognition of potentially harmful products require improvement and, thus, efforts of pharmacovigilance authorities and healthcare providers must jointly act to minimize risks and protect consumers. Manufactures must spend utmost care in providing users with clean and unadulterated products and should be held liable if this accidentally or carelessly fails. Finally, consumers should develop a more critical attitude towards the expectations and hopes associated with DS use in largely healthy individuals, and turn to measures for which safety data are known, and efficacy is proven.
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99 Shah NL, Zacharias I, Khettry U, Afdhal N, Gordon FD. Methasteron-associated cholestatic liver injury: clinicopathologic findings in 5 cases. Clin Gastroenterol Hepatol 2008; 6: 255–8.
100 Kafrouni MI, Anders RA, Verma S. Hepatotoxicity associated with dietary supplements containing anabolic steroids. Clin Gastroenterol Hepatol 2007; 5: 809–12.
101 Krishnan PV, Feng ZZ, Gordon SC. Prolonged intrahepatic cholestasis and renal failure secondary to anabolic steroid-enriched dietary supplements. J Clin Gastroenterol 2009; 43: 672–5.
102 Schwingel PA, Cotrim HP, Salles BR, et al. Anabolic-androgenic steroids: a possible new risk factor of toxicant-associated fatty liver disease. Liver Int 2010. DOI: DOI: 10.1111/j.1478-3231.2010.02346.x.
103 WHO. WHO Guidelines on Safely Monitoring of Herbal Medicines in Pharmacovigilance Systems. Geneva: WHO, 2004.
104 Garcia-Cortés M, Lucena MI, Pachkoria K, et al. Evaluation of Naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury. Aliment Pharmacol Ther 2008; 27: 780–9.
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109 Fontana RJ, Seeff LB, Andrade RJ, et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. Hepatology 2010; 52: 730–42.
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Dangerous Herbs:
Two good examples in this category are Ephedra and Blue Cohosh. Ephedra
has often been used in weight loss products. It was once banned but
seems to now be in some sort of grey area. The problem is that it could
kill you. The substance in it is chemically similar to epinephrine, and
it could cause a heart attack, amongst other things.
Blue cohosh is sometimes recommended to speed childbirth. The good news is that it can do just that. The bad news is that both mother and child could die before the baby is even born. Infants have been born having heart attacks because their mother took blue cohosh.
Cautionary Herbs: Some herbs may be effective, but the number of side effects, interactions or preparation methods makes herbalists nervous unless properly prepared. Cherry bark is great for stopping a cough, but it isn't something for those who don't know how to prepare it to work with. The principle that helps stop the cough is cyanide, and too much of that will kill you.
Licorice is another good example. The problem here are the side effects and interactions. The root is high in sugar, so it could cause problems in diabetics. It raises blood pressure, so it could cause problems for those with high blood pressure or heart disease. In fact, it can cause heart rhythm problems in healthy people.
GRAS: This acronym stands for "generally recognized as safe." While these herbs do have side effects and interactions, most people can take them safely. Chamomile, garlic, lemon balm and so forth are all on this list.
There are three ways herbs can have a major effect on your body. Knowing the herb and what these terms mean may help you make the right decision.
Interaction: This problem happens when two things are combined that react to each other. If you've ever done the "volcano" experiment, you've seen one outside your body. If you mix vinegar and baking soda, it will foam up. Some herbs do that inside the body, both with other herbs and with medications. While this is all right on occasion, most of the time interactions are not considered good things.
Side Effects: The main action of chamomile is to help calm a person down. One of the side effects is it makes that person sleepy. Another is that it could cause uterine contractions. These side effects can be a problem if you're driving somewhere or you're pregnant. That's what a side effect is; something other than the main reason you're taking the supplement.
Medical Conditions: Conditions such as diabetes, heart disease and immune function diseases can all react negatively to certain herbs. I've already mentioned licorice, which covers the first two. When it comes to the immune system, another popular herb is a problem. It is not advised to take Echinacea if you have any problem that affects that system.
Choosing the right supplement is not like picking out a new pair of shoes. Talk to your doctor, your pharmacist and if possible a qualified herbal practitioner. We may be able to help you find a supplement that is right for you and doesn't do you more harm than good.Nov 10, 2011 "Share your voice on Yahoo! websites. Start Here."
Nov 8, 2011 | By Theresa Rosenthal
During pregnancy, the average woman should consume about 2,500 calories a day instead of the approximately 2,100 calories necessary before pregnancy. Consumption of any health or supplement product during pregnancy should contribute to these caloric needs, rather than restrict them. Diet shakes in general may safely be consumed during pregnancy when taken as a snack and not a meal-replacement. Herbalife products have some health and financial concerns that should be taken into consideration, especially during your pregnancy. Please consult with your physician about what supplements are appropriate for your pregnancy diet.
Dieting While Pregnant
Herbalife produces many different products for various needs, though many people use the protein shakes for weight management or fitness goals. The most important thing to remember during your pregnancy is that dieting is not recommended. Extra calories are needed each day for your body and your developing baby. Restricting these calories could cause problems for you and your baby’s growth due to malnutrition. Diet products, such as Herbalife weight management supplements and protein shakes, are not prohibited during pregnancy unless you’re using them to diet, or relying on them every day for your nutritional needs. Please consult your physician before adding supplements to your pregnancy diet.
Herbalife While Pregnant
Herbalife offers an entire line of products to support weight management, digestive health, personal care, energy, fitness, immune system and heart health. Each product solution offers a variety of herbal formulas, beverages, shampoos and skin care. While you may opt for the protein shakes under the fitness category or a nutritional shake from the weight management product line, make sure you are using them only in addition to healthy meals, not as a replacement. Since there are several Herbalife products, each one should be considered separately for their respective ingredients. Remember to consult your physician before making supplemental changes to your pregnancy diet.
Herbalife Dangers
According to the Herbalife website, Herbalife is a multilevel marketing program and the products can only be purchased through independent distributors. Nextag.com compares the prices of products across the Internet and reveals the cost of Herbalife products to be fairly expensive. For example, two shake mix containers are $58. Depending on how often you will be consuming the products, this may be an expensive investment. While money may not be a concern to some pregnant mothers, others should take note that these expensive Herbalife products are not needed nor necessarily recommended for a healthy pregnancy.
References
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The Side Effects of a LiftOFF HERBALIFE Energy Drink
Jun 30, 2011 | By
Energy drinks have exploded in
popularity during the past 10 years. Most of these products include a
proprietary blend of ingredients. Some drinks come in a beverage can,
whereas others such as Liftoff come in a tablet form. According to the
Herbalife website, Liftoff contains substances known to enhance mental
performance and boost energy. While often effective, these ingredients
can cause allergic reactions in some people. Speak with a licensed
physician before consuming a large quantity of energy drinks.
Caffeine
Most energy drinks contain caffeine -- a substance known to increase performance and alertness. Ingesting this stimulant provides benefits to athletes in both individual and team sports, according to a December 2010 review in "Sports Medicine." Yet, caffeine can also cause side effects. An article published in the 2011 volume of the "Polish Heart Journal" describes some of these effects. Large doses can elevate blood pressure and cholesterol count. Pregnant women should also avoid the stimulant. It can have adverse effects on the growth and heart of the fetus.
Most energy drinks contain caffeine -- a substance known to increase performance and alertness. Ingesting this stimulant provides benefits to athletes in both individual and team sports, according to a December 2010 review in "Sports Medicine." Yet, caffeine can also cause side effects. An article published in the 2011 volume of the "Polish Heart Journal" describes some of these effects. Large doses can elevate blood pressure and cholesterol count. Pregnant women should also avoid the stimulant. It can have adverse effects on the growth and heart of the fetus.
Guarana
The Paullinia cupana plant -- better known as guarana -- remains popular despite safety concerns. Guarana has a protective effect on your body as habitual users appear less likely to develop diabetic symptoms, according to a February 2011 report in "Phytotherapy Research." Many over-the-counter supplements adversely affect the kidneys. A case report presented in the March 2007 issue of "Orvosi Hetilap" suggests that long-term use of guarana leads to organ damage. Years of supplementation caused kidney failure in a 30-year-old female patient. This damage disappeared when the women stopped taking guarana.
The Paullinia cupana plant -- better known as guarana -- remains popular despite safety concerns. Guarana has a protective effect on your body as habitual users appear less likely to develop diabetic symptoms, according to a February 2011 report in "Phytotherapy Research." Many over-the-counter supplements adversely affect the kidneys. A case report presented in the March 2007 issue of "Orvosi Hetilap" suggests that long-term use of guarana leads to organ damage. Years of supplementation caused kidney failure in a 30-year-old female patient. This damage disappeared when the women stopped taking guarana.
Ginseng
Ginseng can slow the aging process and improve thinking, according to a December 2009 review in the "Chinese Journal of Integrative Medicine." These benefits may come at a price as ginseng can also cause allergic reactions. A clinical trial described in the July 2004 edition of the "Annals of Medicine" discovered a potential drug interaction associated with ginseng use. Participants taking warfarin, a blood-thinning drug, also received ginseng for three weeks. Relative to baseline, ginseng significantly reduced the effectiveness of warfarin. This change could prove fatal in some cases.
Taurine
Beverage makers often add the organic acid taurine to their energy drinks. This substance reduces fatigue and enhances performance, according to a February 2004 article in "Amino Acids." Taurine also helps the body process sugar. A study published in the 2011 volume of "Biomedical Research" showed that its antioxidant effects protect the body from diabetic damage. Yet, these beneficial effects can cause problems as well. A February 2002 report in "Platelets" indicates that taurine reduces blood coagulation by about 10 percent. This change could prevent wound healing in susceptible people.
Beverage makers often add the organic acid taurine to their energy drinks. This substance reduces fatigue and enhances performance, according to a February 2004 article in "Amino Acids." Taurine also helps the body process sugar. A study published in the 2011 volume of "Biomedical Research" showed that its antioxidant effects protect the body from diabetic damage. Yet, these beneficial effects can cause problems as well. A February 2002 report in "Platelets" indicates that taurine reduces blood coagulation by about 10 percent. This change could prevent wound healing in susceptible people.
Ginkgo
The Ginkgo biloba tree provided traditional societies several medicines. Modern researchers have obtained documentation for some of these alleged effects. Ginkgo improves symptoms of dementia, according to a 2011 paper in "Neuropsychiatric Disease and Treatment." It might also relieve ear ringing in patients with hearing loss. Effective in the short-term, the long-term safety of ginkgo remains unknown. A review published in the January 2008 issue of the "Journal of Food Science" described several possible side effects of ginkgo. Most reactions are mild, but some can be severe. Doctors, for example, have observed near fatal cases of internal bleeding following extended ginkgo use.
The Ginkgo biloba tree provided traditional societies several medicines. Modern researchers have obtained documentation for some of these alleged effects. Ginkgo improves symptoms of dementia, according to a 2011 paper in "Neuropsychiatric Disease and Treatment." It might also relieve ear ringing in patients with hearing loss. Effective in the short-term, the long-term safety of ginkgo remains unknown. A review published in the January 2008 issue of the "Journal of Food Science" described several possible side effects of ginkgo. Most reactions are mild, but some can be severe. Doctors, for example, have observed near fatal cases of internal bleeding following extended ginkgo use.
References
- Herbalife; Liftoff: Product Details
- "Sports Medicine"; Dietary Supplements and Team-Sport Performance; David Bishop; December 2010
- "Polish Heart Journal"; Coffee and Caffeine -- Enemies or Alliantes of a Cardiologist?; Wojciech Dworzanski, et al.; 2011
- "Phytotherapy Research"; Habitual Intake of Guarana and Metabolic Morbidities: An Epidemiological Study of an Elderly Amazonian Population; C. Costa Krewer, et al.; February 2011
- "Orvosi Hetilap"; Acute Renal Failure Caused by Plant Extract; Katalin Vagasi, et al.; March 2007
- "Chinese Journal of Integrative Medicine"; New Achievements in Ginseng Research and Its Future Prospects; Shi-Feng Chu and Jun-Tian Zhang; December 2009
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Continuous reporting of new cases in Spain supports the relationship between Herbalife® products and liver injury.
Pharmacoepidemiol Drug Saf. 2011 Oct;20 (10):1080-7. doi:10.1002/pds.2180. Epub 2011 Jul 12.
Manso G, López-Rivas L, Salgueiro ME, Duque JM, Jimeno FJ, Andrade RJ, Lucena MI.
Source
Centro de Farmacovigilancia de Asturias, Facultad de Medicina, Universidad de Oviedo, Oviedo, Spain. gmanso@uniovi.es
Abstract
PURPOSE:
Previous publications have linked Herbalife® products to hepatotoxicity. The identification of earlier cases in which the culprit agent could not be established raised the hypothesis of a possible contamination of some specific batches of Herbalife products.METHODS:
We searched the Spanish Pharmacovigilance Centres' database of adverse reactions for reports of liver injury associated with the use of Herbalife products from 2003, when the first case was submitted, through September 2010.RESULTS:
The search resulted in 20 reports of liver damage (mean age, 49 years; 16 women), with 12 patients (60%) requiring hospitalization. Hepatocellular damage predominated, and nine (53%) of the hepatocellular cases with bilirubin values were jaundiced, fulfilling the Hy's law criteria, which increases the risk for serious outcomes. Two patients experienced a positive rechallenge. One patient developed cirrhosis, whereas all the others recovered. Causality assessment by the Karch and Lasagna modified algorithm showed a category of definite in 1 case, probable in 14, and possible in 5. Analysis of the different Herbalife products that each patient had taken did not enable us to identify any commonly known hepatotoxic ingredient.CONCLUSIONS:
Our results support the relationship between the consumption of Herbalife products and hepatotoxicity, underscore the concern regarding the liver-related safety of this dietary supplement, and emphasize the need to establish further regulatory measures.Sep 1, 2011 | By
Headache
Guarana may be an effective short-term treatment for headaches, according to the University of Colorado Denver College of Pharmacy. However, guarana is not recommended for treatment of chronic headache, and should not be taken for more than seven days in a row, in order to reduce the risk of side effects such as nausea, anxiety, irritability and increased heart rate.
Tea
Guarana tea is often made by dissolving powered guarana berries in hot water. For optimal results, combine a half to 1 tsp. of powdered guarana with 8 oz. of hot water, recommends CrazyForTea.com. Alternatively, purified guarana supplements can be taken, at a dose of 200 to 800 mg, reports A Nurse's Guide to Herbal Remedies.
Active Ingredient
The likely active ingredient in guarana tea responsible for the effect on headache is caffeine, explains the New York University Langone Medical Center. Although other related stimulants, including theobromine and theophylline, may also play a role. Caffeine is often an effective treatment for headaches for people who do not regularly consume caffeine, according to an article published in the May 2007 issue of the medical journal "Neurological Sciences."
Too Much Caffeine
While occasional consumption of caffeine, in guarana tea or other forms, may be beneficial for headaches, frequent consumption of guarana tea may actual result in more headaches, warns the article in "Neurological Sciences." Long-term consumption of caffeine can lead to physical dependence, which causes withdrawal in the absence of caffeine. One of the common symptoms of caffeine withdrawal is headache, sometimes chronic headaches.
ReferencesArticle reviewed by Tina Boyle Last updated on: Sep 1, 2011 | By Matthew Busse
References
- A Nurse's Guide to Herbal Remedies: Guarana
- New York University Langone Medical Center: Guarana
- University of Colorado, Denver College of Pharmacy: Guarana; Kelvin Anderson; May 2003
- "Neurological Sciences"; Caffeine and Headaches; R.E. Shapiro; May 2007
- CrazyForTea.com: Guarana Herb - Herbal Tea
- HERBALIFE SIDE EFFECTS- 21 DAY CLEANSE
-
RepspaceThe Business Network for Work From Home ProfessionalsCLIPDUDE Posted: 02-03-2011 9:09 AM
I became a distributor in January 2010, I faithfully used all the products and felt great for some time, in May I had my annual physical and was healthy. I started feeling tired around the end of May so I ordered the 21 Day Herbal Cleanse. I started the 21 Day cleanse the first week of June, following all label instructions to the letter as I did with all my Herbalife products.
I woke up June 20, 2010 with chills and a high fever of 104.8 and severe abdominal pain. My wife wanted me to go to the emergency room but I told her it was probobly a bug and would pass, it did not and after three days of excruciating pain I went to the hospital. My colon was almost completely clogged and ruptured, I had emergency surgery to remove 90% of my colon and appendix. I woke up with a colostomy bag and spent almost a week in the hospital. I spent three months recovering from surgery, and then I had the remaining six inches on either end of my colon reconnected. I quit using Herbalife products after my first surgery as the shakes would bind me up, no matter how much water I drank, I would not have any bowel movement for days. I contacted Herbalife and was asked what products I had been taking, I gave a list of all products and lot numbers and expressed concerns that labels should state that products may not be safe for everybody and I could no longer sell a product that I felt was unsafe, Heralife offered to repurchase most of my products. I had a very bad experience with Herbalife products and could not recommend them to anyone. While I cannot prove the Herbalife products caused my colon to clog and rupture, I can say for a fact that I had a colonoscopy 18 months earlier and my colon was healthy.
Jeffrey Raum, Sharpsburg, Ga.
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Image: Fu Fang Shuo / photo
Sunday, October 16, 2011
The Moderator I hereby thank the legislators Miss Tian Qiujin 2011.08.12 in the Legislative Yuan generous attempts to help the victims of Herbalife held a press conference!
Image: Fu Fang Shuo / photo
(Please read the following three reports, victim statements and related laws and regulations continue reading)
Reported (a) the new head capsule Fu Fang Shuo / Taipei
The allergic When detox direct sales nutrition risk kill elderly man
Eat nutritious health food have to be careful! Surnamed Zhang old man eating son bought for his well-known health food "Herbalife" Unexpectedly, the symptoms of systemic redness peeling, dealers also argued that "detoxification" and told the old man to continue to eat, causing the elderly man peeling pus , memory loss, confusion, and nearly died. The man surnamed Zhang the son Zhang Bingshen today (12) morning, accompanied by DPP Legislator Tien Chiu pansy held a press conference, broadside dealer disregard for human life, requiring manufacturers to provide compensation. However, the scene of the senior manager of the the Herbalife Public Affairs Shih Yi-Ru Reason Law, Herbalife tenable, the two sides talking to no intersection.
Zhangbing Shen pointed out that more than seven years old, his father, filial heart, before buying a lot of high price of Herbalife nutritional supplements nutritional supplements. Unexpectedly, the father, after eating, the body begins to redness, itchy situation, asking different Distributor, expressed normal detoxification ", ZhangFu continued safe to eat. Subsequently led to the February 2009 to March 2010, Zhang parent total emergency 4 times, hospitalized six times, almost died of sepsis. The physicians highly suspected food allergy with Herbalife, stop eating, allergic condition immediately improved.
Zhang Bingshen broadside, Herbalife registered with the Department of Health Food Distributor has swindle called "health food", even "detox" efficacy, harm his father almost lost his life, and he suspected Herbalife with false advertising, deception Distributors and consumers, the end of the day, victimized consumers, fined Distributors Corporation was entirely responsible without warnings do not want to raise very unreasonable.
Yi-Ru Shi said, Herbalife clearly marked for each nutritional supplements are "food", and therefore do not need to carry a boxed warning. To the proceedings for this event can not be directly prove ZhangFu allergy symptoms Herbalife Food-related training courses for direct sales personnel requirements shall not claim to have medical benefits. But for the poor direct sales personnel, Herbalife can not be responsible. Herbalife to appoint lawyers also said that if any harm acts of goodwill, it will take action.
Zhang Bingshen stressed that he will get justice if the Herbalife think he deliberately hurt goodwill, "Welcome to the divisions", but if subsequently proved to be the responsibility of Herbalife. The two sides talk past each other in the press conference, there is no intersection.
Wang Huiying, food inspection chief of the Department of Health, said that after the incident, has all Herbalife products sent to the health unit of a comprehensive test, the tests meet the standards for exaggerated advertising section open penalty. She called on the people, nutritional supplements are not equal alternative to dinner, no efficacy and if unwell situation should immediately stop eating, and a doctor as soon as possible.
Reported (2) CNA He Mengkui / Taipei
Codex Alimentarius loophole legislators Yuxiu law
Democratic Progressive Party Legislator Tien Chiu pansy, said today that the citizens have told her petition severe allergic dietary supplement products, related industry should indicate the product ingredients may react, her proposal would amend the law to fill loopholes in the law.
Petition populace Mr. Zhang morning held a press conference in the field autumn pansy accompanied pointed out, the 73-year-old father after taking Herbalife nutritional supplement products, severe allergies, direct sales staff claimed detoxification reaction to his father continued to take the last almost caused sepsis.
Mr. Zhang stressed that his father is not the case, calling for all the victims out to prove, adding "Herbalife victims Union". He believes that Herbalife should carry a boxed warning on the product and training good first-line pharmaceutical salesman knowledge, do not ignore the lives and safety of consumers.
The indictment of Mr. Zhang, Shi Yi-Ru, the Herbalife Public Affairs Manager, Herbalife sell food instead of healthy food, in accordance with the laws and regulations of the Republic of China does not have a boxed warning, but HE Bao Fuji in the enterprise responsibility has a boxed warning on the product, and also requires the distributor can not be claimed that the product has the effect of efficacy or detoxification.
He countered, before the onset of his father, Herbalife and not food boxed warning, he reflects, Herbalife was boxed warning. He also criticized the Department of Health connivance Herbalife endangering the health of citizens, leaving it without human testing, the poison test the product, he decided to make the country lose the lawsuit.
Wang Huiying, section chief of the Department of Health, Food and Drug Administration said after receiving the case, the Department of Health (DH) has for the first time require health unit survey also investigated products advertising content, including raw materials and heavy metals testing, found to meet the health food-related laws and regulations, but exaggerate the efficacy. She called on the people not to believe the the puffery advertised effect, if there is not, we must seek medical treatment as soon as possible, otherwise the expensive and beverages.
TIAN Qiu Jin of Mr. Zhang Lao disabling symptoms disappeared after the Herbalife products, but Herbalife has nothing to do with the consumption of Herbalife also said that Mr. Chang symptoms, consumers are significantly disadvantaged, her proposal would amend the law to make up legal loopholes.
Reported (3) Epoch Shi Chi Yin / Taipei
Eat Herbalife allergenic mistakenly when the detoxification Desk old man insurance dead
Legislator Tien Chiu pansy accompanied the petition by Zhang Bingsheng the 12th held a press conference to point out that the father after taking Herbalife nutritional supplement products, severe allergies, and direct sales staff has said that a detoxification reaction to his father continued to take the last almost causing sepsis .
Zhang Bingsheng filial heart, before buying the high price of Herbalife nutritional supplements nutritional supplements. Unexpectedly, the father, after eating, the body begins to redness, itching, and even body peeling, edema, exudate situation, asking different distributor expressed normal detoxification ", the To ZhangFu continued safe to eat.
He said that his father during the taking total emergency 4 times, hospitalized six times, almost died. Stated on the certificate of the physician's diagnosis: allergies, suspected health food due to Staphylococcus aureus bacteremia. "The physician recommends disabling Herbalife products, allergic condition immediately improved.
He pointed out that Herbalife registered with the Department of Health Food Distributor has swindle called "health food", and even the efficacy of "detox".
To Shi Yi Ruqiang tune, Herbalife, Public Affairs Manager, Herbalife sold food health food, but based on corporate responsibility in a boxed warning on the product in accordance with the laws and regulations do not have to carry a boxed warning, In addition, to the proceedings for this event can not be direct proof sheets Father allergy symptoms with Herbalife food, also require the distributor can not be claimed that the product has the effect of efficacy or detoxification.
The Food and Drug Administration food group, food inspection the registration section chief Wang Huiying said, in this case occurred, has been Herbalife's products to send health units inspection, including the inspection of raw materials and heavy metals test compliant and abnormal. However, she said, Herbalife's advertising propaganda, really exaggerate the phenomenon open penalty for puffery and require improvements.
She also called on the people, and nutritional supplements are not equal alternative to dinner, and also do not have any efficacy, the body does not appear the case, should immediately stop eating, consult a doctor as soon as possible.
Finally, TIAN Qiu Jin of Mr. Chang disable Herbalife products after the symptoms disappear, the symptoms associated with the consumption of Herbalife, Herbalife's resolutely old gentleman's nothing to do, obviously disadvantaged consumers, her proposal would amend the law to make up for the loopholes in the law .
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Sunday, February 13, 2011
Painful experience, that ring
Severe allergic reaction) Painful experience, that ring
As readers have asked about my father-onset detailed symptoms In this description:
Initial symptoms: itchy skin.
Medium-term symptoms: skin itching intensified / skin redness / fever.
Late symptoms: fever / skin redness / edema / limbs peeling skin.
Late symptoms: fever / skin redness / edema / limbs peeling skin.
The serious period symptoms: systemic peeling skin peeling / limbs, edema, exudate / limbs sore knee bent difficult / memory loss and confusion.
Sequelae: abnormal skin / memory loss and confusion.
Sequelae: abnormal skin / memory loss and confusion.
If
you have similar symptoms Do not listen to the detoxification argument
should quickly stop taking it, seek medical attention and contact the health food and gelcap like food unexpected reaction reporting system, to avoid becoming another victims of human trials of health food persons.
Victim statement:
My father is Herbalife victims press conference the parties, the facts of the case on behalf of my father statement is as follows:
1) court proceedings has not yet made a judgment of my father's illness has nothing to do with Herbalife, and we find that the judicial and medical personnel involved in the documented false or forged instrument is suspected, however, the case prosecutor not to prosecute is insufficient evidence. Therefore, I propose to committal for trial, to fight for the last axiom justice ditch, looking forward to the judicial officer ought to be based on the relevant medical diagnosis to confirm the causes of my father with a considerable degree of causality with Herbalife, and references the relevant administrative regulations to prosecute the company .
2) to my father to buy Herbalife products consumption sister, is not myself Zhang Bingsheng purchased. Sister joined Herbalife Distributors on the occasion, my father has also support 12 million to obtain the Distributor qualifications. This product can only be obtained from Herbalife Distributor, most direct marketers are the friends and family as a product of the object sharing, so my father will through the hands of the sister consumption of Herbalife, which is pass the direct selling industry norm man runs into trouble.
3) Herbalife representative of its own products are "food" rather than "health food" or "health food" as prevarication words of shirking its responsibility, but in accordance with the existing laws and norms, claiming to provide special nutrients and health benefits of the food, as the Health Food Control Act of objects.
The 4) Herbalife ingots food should be registered in accordance with the input gelcap like food inspection approved, rejected, principles and other regulations of the supplement to the application for inspection, but the Herbalife Company and Chief, Department of Health did not put forward the inspection audit nuclear provable.
5) The Chief, Department of Health (DH) has not proposed to send test of inspection Herbalife products are in line with the standard of the report proved empty rumor.
6) the position of the Chief, Department of Health and insights are similar with Herbalife, how can we expect the Department of Health, the Food and Drug Administration "due diligence to back the people's health and food safety checks? No wonder conscience physician bluntly critical of the establishment of the esophagus Bureau is simply a hoax!
7) We demand the HE HE Fu home claimed regular clinical experimental track "proved and approved by the Department of Health inspection to prove, to prove that the products are in line with the laws and regulations.
8) I also asked Herbalife written communications report to the head office of the United States proved to show my father victimization return, I am advised by the company at the beginning of the incident, my father was the victim of the case shall be sent to the U.S. company to do causality identification, I wait for the Corporation identification results. (My Herbalife company inform the U.S. company my father's case, doubt it!)
9) Please Herbalife produce product liability insurance contract content to us consumers to prove the performance guarantee of product safety, to maintain their own goodwill.
10) due to the Herbalife product liability and the production of the source of defective products are the U.S. company, so we really object of claims is also the source. If due compensation in the future, I will be the claimant the gold as social things needed to take care of my father, which was I set up the grounds and purposes of Herbalife victims League. I also call upon the people to join our ranks, and jointly safeguard the security and interests of its own and I have the same philosophy and goals.
Summing up the theory, Herbalife products are in clear violation of existing laws and norms, and the security of the product is unknown, however, the section chief of the Department of Health and Herbalife representative statement significant breach of professional conscience and morality. Shi Yi-Ru, the Herbalife Public Affairs Manager, said the company sold food, not health food, do not have to carry a boxed warning required, based on corporate responsibility, but the company has been filling in the product, and also requires the Distributor product efficacy can not be claimed, Herbalife company issued a statement, said the Prosecutor's Office of the High Court disposes of the book clearly old man surnamed Zhang cases can not be, directly or indirectly, to prove any association with Herbalife products ... however these exposition and unconvincing!! (Also, please see this blog post)
To appeal to Herbalife Distributors should uphold the moral conscience in direct sales, and medical personnel should uphold the ethics of conscience to treat the victims of suspected health food, because you are the first line of the face of the victims, an obligation and responsibility to appeal to the people and government together to prevent harm health food.
Relevant laws and regulations as follows:
(1) health food Q & A (Source: Executive Yuan Department of Health)
What is healthy food? Healthy food means as defined in the Health Food Control Act, the Department has Baojian effect to the labeling or advertising of food; aforementioned alleged health benefits that enough to advance public health or reduce disease risk of harm, and has scientific evidence to support the efficacy of The announcement by the Department of Health, rather than treatment, correction of human disease medicine effectiveness.
Product name without the words "health food", whether it is still healthy food management law? In addition to the product name should, depending on the product and the declared content. Food labeling or advertising content involving the health effects of the announcement by the Department of Health, and shall be subject to the norms of the Health Food Control Act. Other words, not to replace the product name: "health food", "functional food", "food nutrition", "organic food", "natural foods" or other similar names, you can circumvent the law of the management.
Health food inspection and registration should attach components, specifications and other information, by the audit is listed on the product packaging still have marked ingredient recipe? Health food approved after its commercially available product packaging labeling should comply with the sections of the project required by section 13 of the Health Food Control Act, which does not include the product's ingredient recipe, but its contents content marked descending order and marked nutrients and content, mark the way and content should be consistent with the Department of Health, and detailed provisions went ahead to the Department of Health website (www.doh.gov.tw) query.
(2) health food and health food management (Source: Department of Health Food Hygiene Department)
In capsule form, tablet form of food because of its appearance, is easy to be confused with the drugs, the former according to the Bureau of Foreign Trade of the Ministry of Economic Affairs, 1989 announcement tablet form, capsule form of general food should be handled nuclear prepare a letter with the Department of Health input visa " regulations, the industry has long according to their input tablet form needs to be presented to the Department of Health, capsule-shaped food applications for nuclear preparedness; council after the announcement in 1994, restrict the importation of goods, the commission check input Consolidated List of Commodities "in with Ming Syria, the two class appearance of the food should be the Department of Health to apply for the issuance of a license file, so that Lihai relations with the file handle matters input checking.
(3) "domestic vitamin tablets, capsules food inspection and registration of" Q & A (Source: Department of Health, the Food and Drug Administration)
(1) Prior to the Listing, which food must first go through the inspection of registration to the Department of Health or license? Enter the tablet form capsules food "," single product (unilateral) food additives (spices except), special nutritional food, genetically modified food inspection and registration must apply in accordance with the provisions of Article 14 of the Act Governing Food Sanitation announcement food "and" domestic vitamin tablet form capsules food. ......
(4) Inspection of Food Imports Measures (Source: Executive Yuan Department of Health)
Application for inspection of products is one of the following circumstances, adopted by batch inspection, and shall submit the test report, inspection authorities may perform inspection: in accordance with domestic and international product safety information or scientific evidence of significant harm to the human body. ......
(5) Summary of Conclusion (Source: Executive Yuan Department of Health)
... In summary, from a regulatory point of view of some basic concepts can skip summarized as follows:
Food can be divided into general food and health food. "Health food" is just a term of general food is a common noun; "health food" is a proper noun, legal terms, permit registered for healthy food, in order to call it.
The main difference in health food and health food (usually food), health food demands of the specific health benefits, general food shall be prohibited.
All food do not exaggerate, hypocrisy, or concerning the efficacy of the labeling or advertising. The general food of breaches to the Act Governing Food Sanitation Office, involving "health food" and "health benefits" (by the EPA announcement is the limit), then the Health Food Control Act at the Office. Healthy food is designed to apply to the Health Food Control Act.
4. General food in addition to the part have been announced must apply for registration by examination, most do not need registration; health food registration prior permission to enter or production.
Life that should be wasted on the good things, but wasted you see the groom's part of life in the above dogma Declaration, I pitch are ashamed, but still want the general public to have the right of health food and food products in general, the basic concept . Another For one, certified health food has some health benefits, but also the day-to-day care only to receive better health and reduce disease risk function, rather than alternative medicine for the treatment, correction of disease with the body once ailments still should first seek the proper medical channels, do not listen to exaggerate the publicity, or the delay in medical treatment and damage to the body, then the non-healthy food intention.
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Hepatitis C Research and News
Tuesday, January 18, 2011
Review of liver injury associated with dietary supplementsEarly View (Articles online in advance of print)
Felix Stickel 1, Kerstin Kessebohm 2, Rosemarie Weimann 3, Helmut K. Seitz 4
Article first published online: 11 JAN 2011
DOI: 10.1111/j.1478-3231.2010.02439.x
© 2011 John Wiley & Sons A/S
Author Information
1 Department of Visceral Surgery and Medicine, Institute of Clinical Pharmacology and Visceral Research, Inselspital, University of Berne, Berne, Switzerland
2 Institute of Clinical Pharmacology and Visceral Research, University of Berne, Berne, Switzerland
3 Institute of Pathology, University of Berne, Berne, Switzerland
4 Department of Medicine, Center of Alcohol Research, Liver Disease and Nutrition, Salem Medical Center, University of Heidelberg, Heidelberg, Germany
* Correspondence: Correspondence Felix Stickel, MD, Department of Visceral Surgery and Medicine, Institute of Clinical Pharmacology and Visceral Research, Inselspital, University of Bern, Murtenstr. 35, 3010 Bern, Switzerland Tel: +41 31 632 87 28 Fax: +41 31 632 49 97 e-mail: felix.stickel@ikp.unibe.ch
Keywords:
anabolic steroids; Camellia sinensis; cholestasis; hepatitis; retinoid toxicity; toxic liver injury
Abstract
Dietary supplements (DS) are easily available and increasingly used, and adverse hepatic reactions have been reported following their intake. To critically review the literature on liver injury because of DSs, delineating patterns and mechanisms of injury and to increase the awareness towards this cause of acute and chronic liver damage. Studies and case reports on liver injury specifically because of DSs published between 1990 and 2010 were searched in the PubMed and EMBASE data bases using the terms ‘dietary/nutritional supplements’, ‘adverse hepatic reactions’, ‘liver injury’; ‘hepatitis’, ‘liver failure’, ‘vitamin A’ and ‘retinoids’, and reviewed for yet unidentified publications. Significant liver injury was reported after intake of Herbalife® and Hydroxycut products, tea extracts from Camellia sinensis, products containing usnic acid and high contents of vitamin A, anabolic steroids and others. No uniform pattern of hepatotoxicity has been identified and severity may range from asymptomatic elevations of serum liver enzymes to hepatic failure and death. Exact estimates on how frequent adverse hepatic reactions occur as a result of DSs cannot be provided. Liver injury from DSs mimicking other liver diseases is increasingly recognized. Measures to reduce risk include tighter regulation of their production and distribution and increased awareness of users and professionals of the potential risks.
Abbreviations
ALF, acute liver failure; DILI, drug-induced liver injury; DS, dietary supplements; FDA, Food and Drug Administration; HSC/MFB, hepatic stellate cells/portal myofibroblasts
The use of dietary supplements (DS) containing vitamins, anti-oxidants, fibre, trace elements, proteins, amino acids and herbal constituents has become a major health trend in affluent societies (1, 2). Consumption of DS in the USA has doubled to 18.9% of adults admitting their use only between 1999 and 2004 (3, 4); some investigations report their consumption up to 47% in certain subgroups such as among elder, non-smoking females with higher education (5). The rising popularity of DS is probably because of an increased awareness of consumers towards health in general and the desire to prevent diseases by an optimized nutritional status, and the persuasion that these treatments are safe (1, 2, 5, 6). Further, DS do not require prescriptions from health professionals allowing largely unrestricted access to relatively cheap products. Consequently, marketing such products has become a multibillion business largely unregulated by official health authorities (6–8).
In the USA, DS are expected to meet the standards outlined in the Dietary Supplement and Health Education Act published in 1994, which allows distribution without prior approval of their efficacy and safety by the Food and Drug Administration (FDA) (9). This simplified licensing practice does not ensure efficacy and safety in the same strict way as with the approval of conventional medications and treatments. Similarly, the European Union has set forth legislative measures for the distribution and marketing of DS and functional foods that are outlined in the European Commission 2000 White Paper on Food Safety (10, 11). This set of legislation pays tribute to the fact that DS may harbour specific problems because of their complex composition, particularly with respect to quality aspects, and defines guidelines for conducting premarketing in vitro and in vivo studies.
While adverse hepatic reactions from xenobiotics are well documented by pre- and post-marketing pharmacovigilance, the situation for DS is less well depicted as widespread and uncontrolled use and under-reporting prevent the determination of their true incidence. Additionally, a low awareness of users and providers towards their potential harms impedes their recognition as the causative agent in incidents of hepatotoxicity. Consequently, estimates of the frequency of DS-associated hepatic injury are likely imprecise and, possibly, too low. The proportion of hepatotoxicity ascribed to DS varies from 2% in a Spanish study (12) describing 531 cases of drug-induced liver injury (DILI) to approximately 10% in a series from the US Drug-Induced Liver Injury Network (DILIN) (13). Figures were as high as 35% in a small series of 20 patients developing acute liver failure with DS exposure as the only identifiable cause of liver damage (14).
Our article aimed to review and describe the literature on liver injury because of DS, delineate patterns and mechanisms of injury and to increase the awareness towards this possible cause of acute and chronic liver damage.
Literature search methodology
In February 2010, case reports and series thereof on liver injury specifically occurring following the consumption of DS published between 1990 and 2010 were searched in PubMed and EMBASE data bases using the terms ‘adverse hepatic reactions’, ‘anabolic steroids’, ‘Camellia sinensis’, ‘dietary/nutritional supplements’, ‘Herbalife’, ‘hepatitis’, ‘Hydroxycut’, ‘green tea’, ‘liver failure’, ‘liver injury’, ‘Noni’, ‘retinoids’, ‘vitamin A’ and critically reviewed. Retrieved publications were searched for yet unidentified publications. Remedies were considered DS if consumed as an aid to improve nutritional status, to loose weight or to treat constipation. Cases of liver injury from preparations taken for other causes than nutritional purposes were not included. No language restriction was used.
| Dietary supplement | Indication for use | Liver lesion | Toxicity mechanisms |
|---|---|---|---|
| |||
| Herbalife® | Various (weight loss, nutritional support, ‘well-being’) | Variable (acute and chronic hepatitis, cholestasis, cirrhosis, hepatic failure) | Unknown; autoimmunity? Bacterial contamination? |
| Camellia sinensis (green tea) | Weight loss | Acute hepatitis | Oxidative stress from (−)-epigallocatechin gallate? |
| LipoKinetix® | Weight loss | Acute hepatitis | Uncoupling of respiratory chain? |
| Hydroxycut | Weight loss | Acute and/or cholestatic hepatitis, liver failure | Unknown |
| Senna (Cassia angustifolia) | Constipation | Variable (acute hepatitis, granulomatous hepatitis, cirrhosis) | Drug idiosyncrasy (CYP2D6 variation)?; uncoupling of respiratory chain? |
| Noni juice (Morinda citrifolia) | ‘Immunostimulation’, health tonic | Acute hepatitis, hepatic failure | Unknown; drug-induced autoimmunity? |
| Ma huang (Ephedra sinica) | Weight loss | Acute hepatitis, hepatic failure | Unknown; drug-induced autoimmunity? Oxidative stress? |
| Germander (Teucrium chamaedrys) | Weight loss | Acute, and fulminant hepatitis, chronic hepatitis with fibrosis/cirrhosis | Hepatocyte apoptosis from toxic neoclerodane diterpenoids |
| ‘Onshidou-Genbi-Kounou’, ‘Chaso’ (Japanese herbals) | Weight loss | Acute hepatitis, hepatic failure | Hepatocyte apoptosis due to N-nitroso-fenfluramine |
| Vitamin A | Disease prevention, immune function | Chronic hepatitis, cholestasis, cirrhosis | Fibrosis from HSC/MFB activation; formation of toxic polar retinoid metabolites with concomitant alcohol consumption |
| Anabolic steroids | Muscle build-up | Cholestasis, benign/malignant liver tumours | Dysfunction of biliary transporter |
Specific dietary supplements associated with liver injury
Herbalife®
Herbalife®
(Los Angeles, CA, USA) sells nutritional and herbal supplements as
tablets, capsules, drinks and energy bars for weight control,
improvement of nutrition, ‘well-being’ and cosmetics. In 2006, the stock
market quoted that Herbalife® company had a revenue of US$3.1 billion via online marketing or through independently operating sales agents.
There are so far six published reports on liver damage following the intake of Herbalife®
products since 2007 describing 34 cases from five countries
(Switzerland, Israel, Spain, Argentina and Iceland), although Herbalife® products are sold in at least 60 countries worldwide (20–25). Individual data of all reports are displayed in Table 2.
Pattern of injury was mostly hepatocellular, but mixed and cholestatic
enzyme patterns were also observed. Severity ranged from mild to severe
hepatic damage including cirrhosis and acute liver failure requiring
liver transplantation, which was successful in one patient while the
second died because of post-operative complications. Causality between
intake of Herbalife® products and the evolution of liver injury was assessed by widely used scores (26, 27)
in five of the six reports and considered ‘certain’ in at least five
patients by a positive rechallenge reaction and ‘probable’ in the
majority of the remaining cases (20, 21).
| Author | Patients (n) | Type and number of products | Duration of intake (months) | Type of injury | Outcome | Causality assessment |
|---|---|---|---|---|---|---|
| ||||||
| Elinav et al. (20) | 12 (11F) | Variable; between 6 and 17 different products | 2–28 | Hepatocellular (n=11), mixed (n=1) | Recovery (n=11), death (n=1) | WHO score; certain (n=3; positive rechallenge); probable (n=6); possible (n=3) |
| Schoepfer et al. (21)* | 10 (7F) | Variable; between 3 and 13 different products | 2–26 | Hepatocellular (n=9), mixed (n=1) | Recovery (n=8), liver transplantation (n=1), cirrhosis (n=1) | WHO score; certain (n=2; positive rechallenge); probable (n=7); possible (n=1) |
| Duque et al. (22) | 4 (4F) | Nine different products | 1–26 | Hepatocellular (n=2); mixed (n=2) | Recovery of all four | Not assessed |
| Chao et al. (23) | 1 (F) | Three different products | 2.5 | Mixed | Recovery | WHO score; probable |
| Stickel et al. (24) | 2 (1F) | Variable; between six and eight different products | 12–36 | Mixed (n=1), cholestatic (n=1) | Recovery (n=1), cirrhosis (n=1) | CIOMS; probable (n=2) |
| Johannsson et al. (25) | 5 (4F) | Variable; between two and five different products | 1–7 | Hepatocellular (n=3), cholestatic (n=2) | Recovery (n=5) | RUCAM; probable (n=3), possible (n=2); WHO; certain (n=1), probable (n=2), possible (n=2) |
Specific dietary supplements associated with liver injury
Herbalife® (Los Angeles, CA, USA) sells nutritional and herbal supplements as tablets, capsules, drinks and energy bars for weight control, improvement of nutrition, ‘well-being’ and cosmetics. In 2006, the stock market quoted that Herbalife® company had a revenue of US$3.1 billion via online marketing or through independently operating sales agents.
There are so far six published reports on liver damage following the intake of Herbalife® products since 2007 describing 34 cases from five countries (Switzerland, Israel, Spain, Argentina and Iceland), although Herbalife® products are sold in at least 60 countries worldwide (20–25). Individual data of all reports are displayed in Table 2. Pattern of injury was mostly hepatocellular, but mixed and cholestatic enzyme patterns were also observed. Severity ranged from mild to severe hepatic damage including cirrhosis and acute liver failure requiring liver transplantation, which was successful in one patient while the second died because of post-operative complications. Causality between intake of Herbalife® products and the evolution of liver injury was assessed by widely used scores (26, 27) in five of the six reports and considered ‘certain’ in at least five patients by a positive rechallenge reaction and ‘probable’ in the majority of the remaining cases (20, 21).
Figure 1.
Liver histology from a patient with secondary biliary cirrhosis
following long-term intake of numerous Herbalife® nutritional
supplements contaminated with Bacillus subtilis. (A) Enlargement of
portal tracts with fibrosis, chronic inflammation and porto-lobular
interface activity as well as ductular proliferation of the bile ducts
with reactive changes of the epithelium (HE staining). (B)
Immunohistochemistry with anticytokeratin 7 indicating bile duct such as
loss of biliary lumina and significant lympho-epithelial infiltration
(see arrow).
Green tea is among the most frequently consumed drinks in the USA and often used as a DS. The first report on liver injury following the ingestion of green tea extracts and preparations thereof was published in 1999 (31), and since then, numerous consecutive cases were reported to regulatory agencies worldwide. With effect of April 2003, the manufacturer of Exolise® (Arkopharma, Carros, France), a hydro-alcoholic extract of C. sinensis, has revocated all of their products after altogether 13 cases of acute liver damage following its intake were reported to the French pharmacovigilance authorities (Agence Francaise de Securité Sanitaire de Produits de Sanité; http://www.afssaps.sante.fr/). As a reaction to these accumulating reports, the US Pharmacopeia performed a systematic review of all cases accessible from PubMed, EMBASE and pharmacovigilance data bases in the USA, Canada, UK and Australia reporting on 34 single cases of liver injury following the ingestion of numerous different green tea preparations (32). Herein, case reports were retrospectively evaluated according to the Naranjo causality algorithm scale (33), and 27 reports pertaining to liver damage were labelled as ‘possibly’ and the remaining seven cases as ‘probably’ linked to green tea. Another Medline search review of cases on green tea liver injury from the same year also retrieved 34 published reports and described two further yet unpublished cases (34). On histological examination, livers of patients revealed inflammatory reactions, cholestasis, occasionally steatosis and necrosis. Although there was some overlap of single reports between these two review articles, collected case reports were not identical and jointly provided details on 58 cases of hepatotoxicity along with the intake of green tea extracts, powdered leaves, green tea infusions and hydro-alcoholic and aqueous extracts. In Mazzanti's summary, no causality re-evaluation was performed, but information on de- and rechallenge is provided for every case indicating a positive rechallenge response with accelerated recurrence of liver injury in seven of 36 incidents, which strongly suggests a causal relationship between the observed liver injury and green tea consumption. Of concern is that there was one reported death. However, a note of caution is warranted in many of the cases regarding an exclusive assignment of causality to green tea, because many patients who experienced adverse hepatic reactions also took numerous other products with a published record of hepatotoxicity, such as Cassia angustifolia, Hydroxycut and Ephedra sinica (for all three, please see below). Since these two review articles, additional cases have been published from Belgium reporting on a 42-year-old female patient who developed cholestatic hepatitis 6 months after starting Densitive® (Kerastase Nutritients, L'Oréal, Paris), which contains C. sinensis (35). Upon dechallenge, a full recovery was recorded. Other causes of liver injury were carefully excluded, but formal causality assessment using an established score was not performed. In the second case, jaundice, weight loss and subacute hepatitis developed in a 76-year-old man who regularly drank green tea infusions (36). Histology showed marked necro-inflammation, and transiently elevated antismooth muscle auto-antibodies were suggestive of autoimmunity induced by green tea constituents.
The mode of toxicity derived from green tea still remains incompletely understood but could be because of (−)-epigallocatechin gallate or its metabolite (−)-epicatechin gallate, which, under certain conditions such as fasting, can induce oxidative stress-related liver damage (37). Interestingly, in vitro and in vivo experimental studies have demonstrated both hepatoprotective as well as hepatotoxic properties (37–40). Along this line, support for potentially hepatoprotective activity from green tea extracts comes from clinical studies studying its therapeutic effects in humans with liver diseases including liver cancer, cirrhosis and steatosis. Four randomized-controlled clinical trials, two cohort, one case–control and three cross-sectional studies from China, Japan and the USA were recently subjected to a systematic review and found overall favourable effects from green tea as reflected by reduced mortality, attenuated steatosis and reduced incidence of primary liver cancer (41).
Whether the risks from green tea consumption outweigh their benefits remains open, but current evidence as outlined above suggests a causal relationship between intake of green tea-containing products and hepatotoxicity. Consequently, in their systematic review, the US Pharmacopeia included a cautionary statement on green tea indicating this possibility (32).
Usnic acid
Some years ago, several cases of acute liver failure requiring liver transplantation following the intake of LipoKinetix®, a product extracted from lichens and fungi and sold as DS capsules, were reported (42–45). Onset of liver injury was usually acute with a maximum latency of 3 months and the injury pattern hepatocellular with massive elevations of ALT and AST. Lipokinetix contained usnic acid and was marketed as a weight-loss remedy. Efficacy for this indication was postulated based on its function as an uncoupler of the respiratory chain, which in principle can augment weight loss (46). Apart from usnic acid, LipoKinetix® contained norephedrine hydrochloride, diiodothyronine, yohimbine hydrochloride and caffeine, which were confirmed by analysing the used LipoKinetix® lots. None of the ingredients were associated previously with liver damage and inadvertent contamination was excluded. These serious events caused the withdrawal of LipoKinetix® from the market.
Hydroxycut
Only recently, several Hydroxycut products were retracted by the manufacturer following a warning posted by the FDA in May 2009 because of 23 reports of liver injury including cases with acute hepatic failure and subsequent liver transplantation (47–49). Hydroxycut preparations were sold as powder, capsules and tablets by conventional retailers, through Internet sources and via direct television marketing. Hydroxycut was used to support weight loss and by body builders. The manufacturer had been charged previously with several lawsuits for unfounded health claims. Before May 2009, its primary ingredients included Garcinia cambogia, Gymnema sylvestre, chromium polynicotinate, caffeine and green tea. Published cases were recently reviewed and showed acute onset after several weeks of intake with high levels of serum aminotransferases in the majority of cases, while others presented with a more insidious, usually cholestatic course (50).
Miscellaneous
Various other DS have been associated with acute and subacute liver damage such as Senna (C. angustifolia), which is used as a powder, tea or suppository to treat constipation. According to our search, a total of five reports with altogether five individual cases describe the evolution of variable liver pathologies including acute cytolytic hepatitis, subacute cholestatic hepatitis, acute liver failure and portal vein thrombosis upon consumption of Senna products (51–55). In some reports, Senna preparations were self-made or ingested excessively such as in a young woman taking approximately 10 times the recommended dose who developed cytolytic hepatitis, which completely subsided after stopping Senna (51). The causal relationship between the preparation and hepatitis was confirmed through a positive rechallenge in two cases (51, 52). Senna is biotransformed via intestinal bacteria to rhein anthrone, which is highly reactive and requires binding to glucuronide and sulphate via phase I oxidation for renal excretion (56). Rhein anthrone is suspected to function as an uncoupler of the respiratory chain, and can therefore possibly affect hepatocyte integrity under certain circumstances, such as in genetically predisposed individuals. Seybold et al. (52) describe a case of increased toxicity of Senna tea in a homozygous carrier of a genetic cytochrome P450 2D6 variant rendering the individual a poor metabolizer for phase I hepatic detoxification reactions.
Noni juice (Morinda citrifolia) has become increasingly popular in Western countries as a health tonic. Consumption of Noni was the presumed cause of acute hepatitis in a 45-year-old man who drank a glass of this tropical fruit over several weeks for preventive reasons and for ‘strengthening the immune system’ (57). Other possible aetiologies of acute hepatitis were ruled out and liver tests rapidly turned normal after the cessation of Noni intake. Since this first report in 2005, five additional cases have been published from Austria, Germany and Spain (58–61). Remarkably, two patients experienced liver failure of which one required liver transplantation. The pattern of liver injury was hepatocellular in all cases and occurred rapidly within a few weeks of exposure. Causality was formally assessed in two publications, but not considered ‘certain’ in any of the cases because no rechallenge was used. Also, at least two of totally six patients had concomitant medication with known hepatotoxic potential, such as interferon-β (62) and a Chinese herbal mixture (63) respectively. Responsibility of Noni preparations as the cause of liver injury in these cases is challenged by one of the manufacturers of Noni products (64, 65) by demonstrating experimental evidence of no dose-dependent hepatotoxicity and even hepatoprotective properties in some animal models of chronic liver injury (66, 67). However, a lack of dose-dependent hepatotoxicity does not exclude idiosyncratic drug toxicity, e.g. by inducing autoimmune reaction as shown by Yuce et al. (59) who found excessively high liver–kidney microsomal antibodies of 1:3840 in a patient drinking Noni juice for 4 weeks. Nevertheless, the true underlying pathophysiology of Noni-associated liver injury remains elusive because active components within Noni extracts such as flavonoids, glycosides, vitamins, anthraquinones and polyunsaturated fatty acids are not known to be hepatotoxic.
Chinese herbs have become highly popular among consumers in Western countries because of a prevailing belief in their efficacy and safety. Among many others, Ma huang (E. sinica) is marketed in the USA as a nasal decongestant and bronchodilator, and more recently as a weight-loss remedy. The first report of Ma huang-associated liver injury was about a woman developing acute hepatitis together with elevated antinuclear antibodies (ANA) and smooth muscle antibodies (SMA) after only 3 weeks of intake of Ma huang, but liver abnormalities resolved after its discontinuation (68). Another report suggested that intake of Ma huang was the cause of acute liver failure in a 58-year-old patient initiating her listing for high-urgency liver transplantation who also presented with elevated titres of SMA (69). Another report suggested an association of Ma huang-related liver injury with compound heterozygosity for the C282Y and H63D mutation in the haemochromatosis gene, proposing that excess hepatic iron could aggravate hepatotoxicity, possibly via enhancing oxidative stress (70). The largest series on severe liver injury because of the intake of Ma huang by Neff et al. (71) describes 10 cases of acute cytolytic hepatitis of which two subjects required liver transplantation and one died, while the remaining seven patients recovered spontaneously. These cases of severe liver damage and others referring to cardiac toxicity have prompted a warning by the FDA for the use of Epedra-containing DS such as Ma huang (72).
In 1986, Germander (Teucrium chamaedrys) was approved as a drug for the supportive treatment of obesity in France. Its subsequent widespread use precipitated numerous reports on acute, chronic and even fulminant hepatitis to the French pharmacovigilance authorities in 1992 (73–75). Within a median of 2 months, intake of daily doses between 600 and 1600 mg/day precipitated acute cytolytic hepatitis or chronic hepatitis with fibrosis and even cirrhosis (74, 76). All patients recovered after the discontinuation of treatment, but some relapsed under re-exposure. Germander contains saponins, glycosides, flavonoids and neoclerodane diterpenoids, which were shown to be converted into diterpenoid toxic metabolites by cytochrome P450 3A in mice (77). In conditions of glutathione depletion – such as during fasting – or after induction of cytochrome P450 3A, toxic diterpenoids are potent inducers of hepatocyte apoptosis (78, 79). Hence, in 1992, the license for Germander-containing products was withdrawn.
‘Onshidou-Genbi-Kounou’, another herbal marketed for weight loss, seemed the likely cause of chronic hepatitis in a 52-year-old Japanese woman who took this preparation for 2 months (80). Serum levels of liver enzymes were elevated to >1500 IU/l and ANA were positive with 1:160. All other possible causes for chronic hepatitis were excluded, and liver histology was compatible with drug-induced autoimmune hepatitis. The patient recovered completely without intervention on cessation of ‘Onshidou-Genbi-Kounou’ intake. In a larger series from Japan describing 12 patients with acute hepatitis after taking ‘Onshidou-Genbi-Kounou’ and ‘Chaso’ for weight loss, two patients developed liver failure of which one survived after successful liver transplantation and the other one died (81). ‘Onshidou-Genbi-Kounou’ contains several natural compounds (amachazuru, tea leaf, barbaloin, total saponin and polyphenols) and N-nitroso-fenfluramine. The latter demonstrated induction of mitochondrial permeability transition and hepatocyte apoptosis following uncoupling of oxidative phosphorylation and intracellular ATP depletion (82, 83).
Vitamin A-associated liver injury
DS fortified with vitamin A are used to prevent night blindness, to increase immune function and to promote health in general. Liver injury related to hypervitaminosis A is well known for many decades and comprises mild elevations of serum liver enzymes, cholestatic hepatitis, non-cirrhotic portal hypertension, progressive fibrosis and cirrhosis (84–87). Toxicity does not usually occur with standard doses below 50 000 IU/day as contained in common multivitamin preparations, but individual tolerability may vary (88). Pre-existing liver lesions including steatosis, chronic alcohol consumption, comedication with other potentially hepatotoxic drugs and young age may predispose certain individuals to develop vitamin A hepatotoxicity (89, 90). Several case reports have demonstrated significant hepatotoxicity with vitamin A doses as low as 20 000 IU/day (91), and upper limits of tolerability may even be lower in regular alcohol consumers (92).
Toxicity is mediated to the dose-dependent effect of retinoids on hepatic stellate cells/portal myofibroblasts (HSC/MFB), which are the key effector cells in the evolution of fibrosis and cirrhosis (93). Upon excessive vitamin A exposure, HSC/MFB start to produce collagens, downregulate collagenase activity and acquire the ability of contraction leading to elevation of blood pressure in the portal vein. In addition to this direct impact on HSC/MFB function and activity, retinoids can be transformed into metabolites that affect mitochondrial function and hepatocyte viability with resulting liver cell apoptosis (94, 95). This was shown to occur particularly when co-administered with alcohol. Dan and colleagues showed that retinoids can be transformed via alcohol-induced cytochrome P450 2E1 into highly reactive and toxic polar metabolites, which cause hepatocyte apoptosis upon caspase 3 activation (Fig. 2). Hence, health professionals should consult users carefully about the potential dangers of vitamin A, particularly when intended for longer period, in children and regular alcohol consumers.
Figure 2.
Retinoids are substrates of cytochrome P450 2E1 and may be transformed
into toxic polar retinoid metabolites. These can damage mitochondria by
disrupting the mitochondrial membrane potential, releasing pro-apoptotic
factors (e.g. cytochrome C) and initiating caspase activation and
hepatocellular apoptosis.
Anabolic steroids are an integral part of the nutritional concept of many athletes to improve fitness, muscle gain and exercise performance. Their use is widespread although anabolics are classified as class III substances and therefore subdued to strict rules (96). However, access via inofficial and sometimes illegal sources is easy, and therefore, in spite of tight rules, further adverse hepatic reactions following the consumption of anabolic steroids can be expected. Hepatotoxicity has been frequently described and patterns of injury delineated. Liver lesions include intrahepatic cholestasis, hepatitis, adenoma and hepatocellular carcinoma and rare malformations such as peliosis hepatis, a rare pathological entity characterized by the gross appearance of multiple cyst-like, blood-filled cavities within the liver (97, 98). A recent case series demonstrated the evolution of cholestasis 2 weeks after the intake of anabolic steroids had been stopped. All patients recovered fully after intake had been terminated (99). Even more worrisome is the observation that some DS may contain anabolic steroids sufficient to precipitate liver injury, as demonstrated by a recent case report showing cholestasis in two young men who took DS to enhance their body-building performance (100). Another case presented with a less favourable course as prolonged intrahepatic cholestasis and subsequent kidney failure developed (101). The precise mechanism underlying toxicity is yet unclear, but experimental data indicate direct hepatocellular toxicity from steroids via increased oxidative stress and subsequent impairment of function of the canalicular bile salt export pump (100).
A recent case–control study from Brazil suggested that anabolic steroids could be a cause of toxicant-associated non-alcoholic fatty liver disease (TAFLD) by comparing 95 recreational body builders using anabolic steroids with 85 non-users. In those consuming anabolic steroids, 12.6% of subjects revealed criteria compatible with TAFLD such as steatosis on ultrasound imaging, elevated serum transaminases and exclusion of relevant alcohol intake or concomitant medication, but no overweight or insulin resistance suggestive of metabolic NAFLD. In turn, 2.4% of body builders not using anabolic steroids showed clinical signs and findings suggestive of NAFLD. The authors concluded that the intake of anabolic steroids could be a cause of non-metabolic, but toxicant-associated NAFLD (102).
Conclusion
Hepatic injury secondary to consumption of DS is recognized, although its exact frequency remains unclear, mostly because evidence relies exclusively on case reports. Lack of stringent diagnostic criteria, poor awareness of consumers and prescribers, easy and uncontrolled access and under-reporting account for this epidemiological gap of knowledge. Diagnostic assessment of DS-associated should be made more consistent, and customized specifically to DS. Although causality categories reached in many of the published reports suggest a causal relationship between liver injury and the intake of certain DS products, pitfalls exist related to the used diagnostic scales, which have all been criticized for variable reasons and of which none is unequivocally accepted as being suitable for the evaluation of DS as a cause of liver injury. While the WHO score is not specifically designed to evaluate DILI (103), the Naranjo adverse drug reaction probability scale (33) was recently found to have low sensitivity (54%), poor negative predictive value (29%) and to lack reproducibility in a large series of cases of suspected hepatotoxicity (104) when compared with the Roussel Uclaf Causality Assessment Method (RUCAM) (26, 105). A clinical diagnostic scale has been suggested as a simple tool to assess adverse hepatic drug reactions and showed good correlation with RUCAM in one study (106), but not in another (107). To conclude, all used scores reveal merits and limitations, but a common consensus on which one is the best to apply in causality assessment of DS-associated liver damage has never been reached. In an approach to compensate for this lack of common agreement, recently, the DILIN was established to advance our understanding and research into DILI by initiating a prospective registry of patients with DILI for future studies into host clinical, genetic, environmental and immunological risk factors, and to develop standardized nomenclature, terminology and causality assessment instruments (108). Patients with liver injury because of herbal products are also eligible to be included. Herein, a causality score ranging from 1 (definite) to 5 (unlikely) as well as a severity score ranging from 1 (mild) to 5 (fatal) is applied by three hepatologists of the DILIN study group, thereby minimizing individual biases. In addition to accounting for the input of the reporting investigator who took the history, performed the physical examination and supervised the data collection, a prospective evaluation of other potential causes of liver injury and serial laboratory data through at least 6 months of follow-up are offered. However, the DILIN expert opinion is limited by its lack of generalizability and a low level of agreement between the three hepatologists (109). Hence, a certain degree of inaccuracy in assigning causality remains until better diagnostic measures are established.
Apart from diagnostic measures, better regulatory measures to assure safety and timely recognition of potentially harmful products require improvement and, thus, efforts of pharmacovigilance authorities and healthcare providers must jointly act to minimize risks and protect consumers. Manufactures must spend utmost care in providing users with clean and unadulterated products and should be held liable if this accidentally or carelessly fails. Finally, consumers should develop a more critical attitude towards the expectations and hopes associated with DS use in largely healthy individuals, and turn to measures for which safety data are known, and efficacy is proven.
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What You Don’t Know About
There are two comments bound to make any credible herbalist cringe. One is "It can't hurt me, it's all natural," and the other is "herbs don't have any side effects or interactions." Both are wrong. They can hurt you and they do have side effects and interactions. 
Blue cohosh is sometimes recommended to speed childbirth. The good news is that it can do just that. The bad news is that both mother and child could die before the baby is even born. Infants have been born having heart attacks because their mother took blue cohosh.
Cautionary Herbs: Some herbs may be effective, but the number of side effects, interactions or preparation methods makes herbalists nervous unless properly prepared. Cherry bark is great for stopping a cough, but it isn't something for those who don't know how to prepare it to work with. The principle that helps stop the cough is cyanide, and too much of that will kill you.
Licorice is another good example. The problem here are the side effects and interactions. The root is high in sugar, so it could cause problems in diabetics. It raises blood pressure, so it could cause problems for those with high blood pressure or heart disease. In fact, it can cause heart rhythm problems in healthy people.
GRAS: This acronym stands for "generally recognized as safe." While these herbs do have side effects and interactions, most people can take them safely. Chamomile, garlic, lemon balm and so forth are all on this list.
There are three ways herbs can have a major effect on your body. Knowing the herb and what these terms mean may help you make the right decision.
Interaction: This problem happens when two things are combined that react to each other. If you've ever done the "volcano" experiment, you've seen one outside your body. If you mix vinegar and baking soda, it will foam up. Some herbs do that inside the body, both with other herbs and with medications. While this is all right on occasion, most of the time interactions are not considered good things.
Side Effects: The main action of chamomile is to help calm a person down. One of the side effects is it makes that person sleepy. Another is that it could cause uterine contractions. These side effects can be a problem if you're driving somewhere or you're pregnant. That's what a side effect is; something other than the main reason you're taking the supplement.
Medical Conditions: Conditions such as diabetes, heart disease and immune function diseases can all react negatively to certain herbs. I've already mentioned licorice, which covers the first two. When it comes to the immune system, another popular herb is a problem. It is not advised to take Echinacea if you have any problem that affects that system.
Choosing the right supplement is not like picking out a new pair of shoes. Talk to your doctor, your pharmacist and if possible a qualified herbal practitioner. We may be able to help you find a supplement that is right for you and doesn't do you more harm than good.Nov 10, 2011 "Share your voice on Yahoo! websites. Start Here."
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