Clinical Briefs: Hepatotoxicity Linked to Weight-Loss Supplement
Clinical Briefs: Hepatotoxicity Linked to Weight-Loss Supplement
Source: Favreau JT, et al. Severe hepatotoxicity associated with the dietary supplement LipoKinetix. Ann Intern Med 2002;136: 590-595.
Lipokinetix (syntrax, cape girardeau, MO) is a dietary supplement marketed for weight loss. A possible causal association between LipoKinetix and hepatotoxicity was studied in a case series. Using an outpatient clinic, tertiary care hospital, and U.S. Food and Drug Administration (FDA) databases, seven patients were identified who ingested LipoKinetix and presented with hepatocellular damage between July and December 2000.
All patients developed acute hepatotoxicity within three months of starting LipoKinetix. All reported taking recommended dosages. No patient was taking any other prescription drug. Four were taking other supplements, only one of which was a Chinese herbal formulation. At presentation, symptoms and results of laboratory tests were characteristic of acute hepatitis. All patients recovered spontaneously after LipoKinetix use was discontinued. Three of the seven patients, including one who developed fulminant hepatic failure complicated by cerebral edema, were taking LipoKinetix alone at the time of presentation. Of the four patients who were taking multiple supplements, two resumed taking supplements other than LipoKinetix without incident.
The use of LipoKinetix may be associated with hepatotoxicity. Despite extensive evaluations, no other cause for hepatotoxicity could be identified in the seven patients studied.
Comment
Savvy readers know that the Federal Trade Commission has been more active and more capable in regulating supplement manufacturers than the FDA. But few patients know that the FDA has no authority to review supplements—their composition, purity, dissolution, dosage, proof of efficacy, and potential adverse effects or interactions—prior to marketing. These independently analyzed samples did not contain impurities. They did contain, per capsule, norephedrine hydrochloride (25 mg), sodium usniate (100 mg), 3,5-diiodothyronine (100 mg), yohimbine hydrochloride (3 mg), and caffeine (100 mg).
Acute hepatitis and fulminant hepatic failure are serious illnesses. Will they compel Congress to require that supplement companies meet pharmaceutical manufacturing standards?
Probably not. To paraphrase Senator Dirksen (R-IL, 1926-1969), a billion here, a billion there, pretty soon we’re talking real money. But not yet. Only $4 billion was spent on supplements last year—almost nothing in comparison with pharmaceuticals. The tragedy is that these supplements often act just like pharmaceuticals—with striking adverse effects.
Because phenylpropanolamine, recently withdrawn from OTC preparations for weight loss, is actually racemic norephedrine, and has been associated with hepatotoxicity in animals, it may be the hepatotoxin. Or, the interaction may simply be idiosyncratic, as the authors suggest. They also offer, as do two editorialists, referral to the MedWatch web site (www.fda.gov/medwatch/report/hcp.htm) and toll free number, (800) FDA-1088.
When this adverse event was reported to the FDA in the fall of 2001, the authors recommended removal from the marketplace. But the FDA had no authority and little leverage to require it, much less to discover how this happened. Case reports and series may not offer proof of causality, but no clinician I know needs further formal pharmacoepidemiology studies to warn patients away from this substance, and ones like it.
Recommendation
Recommend that patients immediately discontinue taking OTC weight-loss agents containing caffeine and ephedrine or ephedrine derivatives, or hormone-containing or hormone-related compounds. Their long-term efficacy and short- and long-term safety have not been proven, and it is unfair to balance that proof on the backs of people who have obesity as a disease, just when some well-deserved clinical and research attention is about to be made available to them.
La Puma J. Hepatotoxicity linked to weight-loss supplement. Altern Med Alert 2002;5:86-87Subscribe Now for Access
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