Severe Hepatotoxicity Associated with the Dietary Supplement LipoKinetix

16 April 2002 | Volume 136 Issue 8 | Pages 590-595

Background: LipoKinetix (Syntrax, Cape Girardeau, Missouri) is a dietary supplement marketed for weight loss.

Objective: To describe a possible causal association between LipoKinetix and hepatotoxicity.

Design: Case series.

Setting: Outpatient clinic, tertiary care hospital, and U.S. Food and Drug Administration databases.

Intervention: Routine medical and supportive care.

Measurements: Clinical and laboratory evaluation.

Results: All patients developed acute hepatotoxicity within 3 months of starting LipoKinetix. 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.

Conclusions: 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.

Editors' Notes Context Dietary supplements, unlike drugs, are not tightly controlled by the U.S. Food and Drug Administration (FDA) before marketing. Contribution LipoKinetix, a dietary supplement sold as an aid to promote weight loss, was associated with severe hepatotoxicity in seven previously healthy patients. None had evidence of viral infection or autoimmune disease or had ingested other hepatotoxic drugs. All patients recovered spontaneously after discontinuing use of LipoKinetix. Implications Although the FDA has issued warning letters to the manufacturer, physicians, and the public regarding LipoKinetix, federal oversight of dietary supplements remains problematic. Physicians should inquire about the use of dietary supplements when patients present with evidence of hepatotoxicity. –The Editors

 

Author and Article Information

From Cedars-Sinai Medical Center, Burns and Allen Research Institute, University of California, Los Angeles, School of Medicine, Los Angeles, California; and Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, D.C.
On 19 November 2001, the U.S. Food and Drug Administration released a letter to health care professionals ( http://www.cfsan.fda.gov/~dms/ds-ltr25.html/ ) that contained the following sentence: "We urge you to review your cases of hepatitis in order to determine if any may be related to the use of dietary supplements in these patients."
–The Editors

Acknowledgment: The authors thank Dr. Robert Uyeda, Dr. Mitchell Nishimoto, and Dr. Hitoshi Tomizawa, for bringing these patients to our attention and Dr. Frederick Watanabe for his superb clinical care.

Requests for Single Reprints: Joya T. Favreau, MD, Department of Internal Medicine, Cedars-Sinai Medical Center, Becker Building-120, 8700 Beverly Boulevard, Los Angeles, CA 90048; e-mail, joya.favreau{at}cshs.org.

Current Author Addresses: Dr. Favreau: Department of Internal Medicine, Cedars-Sinai Medical Center, Becker Building-120, 8700 Beverly Boulevard, Los Angeles, CA 90048.

Drs. Ryu, Orshansky, and Park: Department of Internal Medicine, Cedars-Sinai Medical Center, 8700 Beverly Boulevard #5610, Los Angeles, CA 90048.

Dr. Braunstein: Division of Endocrinology, Department of Medicine, Cedars-Sinai Medical Center Center, 8700 Beverly Boulevard #2119-N, Los Angeles, CA 90048.

Mr. Coody: Food and Drug Administration, 200 C Street SW, Washington, DC 20204.

Dr. Love: Office of Regulatory Affairs, 5600 Fishers Lane, Rockville, MD 20857.

Dr. Tse-Ling Fong: Division of Gastroenterology and Liver Diseases, Department of Medicine, University of Southern California Keck School of Medicine, 1355 San Pablo Street, Los Angeles, CA 90033.