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Severe Hepatotoxicity Associated with the Dietary Supplement LipoKinetix

Joya T. Favreau, MD; Mina L. Ryu, MD; Glenn Braunstein, MD; Greg Orshansky, MD; Sean S. Park, MD; Gary L. Coody, RPh; Lori A. Love, MD, PhD; and Tse-Ling Fong, MD
[+] Article and Author 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@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.


Ann Intern Med. 2002;136(8):590-595. doi:10.7326/0003-4819-136-8-200204160-00008
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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.

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Summary for Patients

Liver Failure Associated with the Dietary Supplement LipoKinetix

The summary below is from the full report titled “Severe Hepatotoxicity Associated with the Dietary Supplement LipoKinetix.” It is in the 16 April 2002 issue of Annals of Internal Medicine (volume 136, pages 590-595). The authors are JT Favreau, ML Ryu, G Braunstein, G Orshansky, SS Park, GL Coody, LA Love, and T-L Fong.

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