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ISSN 1007-9327 CN 14-1219/R  World J Gastroenterol  2009 April 14; 15(14): 1786-1787

LETTERS TO THE EDITOR

Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance
 

Ano Lobb


Ano Lobb, Public Health Consultant, 80 Lepage Rd, Barre, VT 05641, United States

Author contributions: Lobb A interpreted and synthesized the data, and wrote this commentary.

Correspondence to: Ano Lobb, Public Health Consultant, 80 Lepage Rd, Barre, VT 05641, United States. ano.lobb@gmail.com

Telephone: +1-802-2797625  Fax: +1-802-4793280

Received: January 14, 2009    Revised: February 11, 2009

Accepted: February 18, 2009
Published online: April 14, 2009

 

Abstract

There is a growing number of case reports of hepatoxicity from the widely marketed weight-loss supplement Hydroxycut, which contains the botanical ingredient Garcinia cambogia. These case reports may substantially undercount the true magnitude of harm. Based on the past experience with harmful dietary supplements, US regulators should assume the more precautionary approach favored by Canada and Europe. Lacking effective adverse event surveillance for supplements, or the requirements to prove safety prior to coming to the market, case reports such as those summarized here assume added importance.

 

Key words: Hydroxycut; Dietary supplements; Garcinia cambogia; Liver failure; Weight loss; Super citrimax; Hca-sx

 

Lobb A. Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance. World J Gastroenterol 2009; 15(14): 1786-1787  Available from: URL: http://www.wjgnet.com/1007-9327/15/1786.asp  DOI: http://dx.doi.org/10.3748/wjg.15.1786

 

TO THE EDITOR

Dara et al[1] report on a case series of two patients with hepatotoxicity associated with the weight-loss supplement Hydroxycut, so named because it contains potentially hepatoxic hydroxycitric acid derived from the tropical fruit Garcinia cambogia[1]. Two earlier case reports in 2005 were also referenced[2]. To this count should be added two additional case reports of hepatoxicity associated with Hydroxycut[3,4]. An estimated 15% of the US population uses dietary supplements for weight loss[5], and Hydroxycut is the top selling product in this class and market, with roughly a million units sold per year[6]. With such wide usage, these six cases may underestimate the true incidence of hepatoxicity by several degrees of magnitude.

Each case report has similarities both in reported liver screening abnormalities and symptoms reported by patients, all of whom were otherwise healthy and experienced normalized hepatic function once they stopped taking the supplement. Table 1 synthesizes key laboratory findings and reported symptoms.

Poor regulation of dietary supplements in the US has been noted by consumer advocates, researchers and policymakers[7-10]. US manufacturers of dietary supplements are not required to conduct trials establishing safety or efficacy prior to marketing; only provide a copy of their label for the Food and Drug Administration (FDA) to review[7,9,11]. Ingredients do not need to be considered “generally regarded as safe” as pharmaceuticals or food additives do, and the FDA must prove that a supplement is harmful before taking regulatory action[9,11]. This means consumers in effect become unwitting subjects in a large scale post-marketing trial of a product’s safety. Unfortunately, the FDA does a generally poor job of post-marketing monitoring of adverse events from supplements, only receiving reports of an estimated 1% of such events[11]. A recent search of FDA’s adverse events surveillance database for “Hydroxycut”, “hydroxycitric acid”, “Garcinia cambogia”, or “SuperCitrimax” (the proprietary blend of Garcinia cambogia used in Hydroxycut) yielded no reports[12]. Furthermore, the nation’s poison control centers, which receive far more supplement adverse event reports than the FDA, lack the necessary coordination to act in a surveillance role[11]. Supplement manufacturers may not be forthcoming with information about emerging health risks from their products. The makers of the weight-loss supplement Metabolife 356, for example, withheld over 14000 reports they had received over 5 years documenting serious adverse events associated with their ephedra-containing product, including myocardial infarction, stroke, seizure and death[7]. (Though not legally mandated to report serious adverse events until 2007[9,11], failure to act on such reports suggests an ethical lapse.) To be fair, the FDA has taken action to protect the public health from dangerous supplements, banning ephedra in 2004 due to its cardiac risk[13]. Formerly a common ingredient in numerous weight-loss supplements, ephedra was banned only after 155 deaths were associated with its use[14]. In contrast, regulators in Canada, the UK and Europe appear to take a more precautionary approach. The supplement kava-kava was banned in Canada in 2002 after 29 cases of hepatoxicity were associated with its use[15], and in the UK and Europe the following year after some 40 more cases were reported[16]. In the US, the FDA has issued a consumer advisory about possible hepatoxicity associated with kava-kava use, but has not banned the substance[17].

Faced with the aforementioned difficulties ensuring the safety of widely used dietary supplements, reliable and transparent case reports such as those cited above assume added importance. They may also underscore the need for US regulators to adopt the more precautionary post-marketing practices of their European and Canadian counterparts. Authorities should also exercise their responsibilities to the public’s health by being empowered to practise more stringent and evidenced-based regulation of these products, many of whom could be considered pharmaceuticals due to their clear pharmacological effects and potent risks[9].

 

REFERENCES

1      Dara L, Hewett J, Lim JK. Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements. World J Gastroenterol 2008; 14: 6999-7004   PubMed   DOI

2      Stevens T, Qadri A, Zein NN. Two patients with acute liver injury associated with use of the herbal weight-loss supplement hydroxycut. Ann Intern Med 2005; 142: 477-478   PubMed   

3      Shim M, Saab S. Severe hepatotoxicity due to Hydroxycut: a case report. Dig Dis Sci 2009; 54: 406-408   PubMed   DOI

4     Jones FJ, Andrews AH. Acute liver injury associated with the herbal supplement hydroxycut in a soldier deployed to Iraq. Am J Gastroenterol 2007; 102: 2357-2358   PubMed   

5      Blanck HM, Serdula MK, Gillespie C, Galuska DA, Sharpe PA, Conway JM, Khan LK, Ainsworth BE. Use of nonprescription dietary supplements for weight loss is common among Americans. J Am Diet Assoc 2007; 107: 441-447   PubMed   

6      Weight control a high priority. Chain Drug Rev 2008; 30: 30

7      Consumers Union. Dangerous supplements: still at large. Consum Rep 2004; 69: 12-17  

8      Bent S. Herbal medicine in the United States: review of efficacy, safety, and regulation: grand rounds at University of California, San Francisco Medical Center. J Gen Intern Med 2008; 23: 854-859   PubMed   

9      Morrow JD. Why the United States still needs improved dietary supplement regulation and oversight. Clin Pharmacol Ther 2008; 83: 391-393   PubMed   DOI

10    United States General Accounting Office. Dietary supplements for weight loss: Limited federal oversight has focused more on marketing than on safety. 2002. Available from: URL: http://www.gao.gov/new.items/d02985t.pdf

11    Gardiner P, Sarma DN, Low Dog T, Barrett ML, Chavez ML, Ko R, Mahady GB, Marles RJ, Pellicore LS, Giancaspro GI. The state of dietary supplement adverse event reporting in the United States. Pharmacoepidemiol Drug Saf 2008; 17: 962-970   PubMed   

12    U.S. Food and Drug Administration. Medwatch: The FDA safety information and adverse event reporting program. Search performed on January 24, 2009. Available from: URL: http://www.fda.gov/medwatch

13    U.S. Food and Drug Administration. Sales of supplements containing ephedrine alkaloids (ephedra) prohibited. 2004. Available from: URL: http://www.fda.gov/oc/initiatives/ephedra/february2004

14    Moran M. Did delay of ephedra ban cause unnecessary deaths? Psych News 2004; 39: 24  

15    Boon HS, Wong AH. Kava: a test case for Canada's new approach to natural health products. CMAJ 2003; 169: 1163-1164   PubMed   

16    Medicines and Healthcare Products Regulatory Agency. MCA investigation of kava-kava leads to ban following voluntary withdrawal. 2002. Available from: URL: http://www.dh.gov.uk/en/Publicationsandstatistics/Pressreleases/DH_4026015

17    U.S. Food and Drug Administration. Kava-containing dietary supplements may be associated with severe liver injury. Consumer advisory, 2002-03-25. Available from: URL: http://www.cfsan.fda.gov/~dms/addskava.html

 

S- Editor Cheng JX   L- Editor Ma JY   E- Editor Zheng XM

 

 

 

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