Liver

Subject Category: Liver

Am J Gastroenterol 2010;105:1561–1566; doi:10.1038/ajg.2010.5; published online 26 January 2010

Hepatotoxicity Due to Hydroxycut: A Case Series

Tse-Ling Fong MD1, Karl C Klontz MD2, Alejandro Canas-Coto MD3, Steven J Casper PhD2, Francisco A Durazo MD4,8, Timothy J Davern II MD5,8, Paul Hayashi MD6, William M Lee MD3,8 and Leonard B Seeff MD7

  1. 1Division of Gastrointestinal and Liver Diseases, University of Southern California, Los Angeles, California, USA
  2. 2Center for Food Safety and Applied Nutrition, US Food and Drug Administration, Bethesda, Maryland, USA
  3. 3Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, Texas, USA
  4. 4Division of Digestive and Liver Diseases, University of California, Los Angeles, Los Angeles, California, USA
  5. 5Division of Gastroenterology, University of California, San Francisco, San Francisco, California,USA
  6. 6Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  7. 7Liver Diseases Research Branch, Division of Digestive Diseases and Nutrition, National Institutes of Health, Bethesda, Maryland, USA
  8. 8The National Institute of Diabetes and Digestive and Kidney Diseases Drug-Induced Liver Injury Network Study Group

Correspondence: Tse-Ling Fong, MD, Division of Gastrointestinal and Liver Diseases, University of Southern California, Keck School of Medicine, 1510 San Pablo Street, 2/F, Los Angeles, California 90033, USA. E-mail: tselingf@usc.edu

Received 7 November 2009; Accepted 21 December 2009; Published online 26 January 2010.

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Abstract

OBJECTIVES:

 

Muscletech Hydroxycut (Iovate Health Sciences Research, Oakville, Ontario, Canada) was a popular weight-loss supplement that was recalled by the manufacturer in May 2009 on the basis of reports of hepatotoxicity associated with this supplement. We sought to characterize the clinical presentation of Hydroxycut-associated liver injury and to adjudicate these cases for causal association with Hydroxycut.

METHODS:

 

We assessed the causality and grading of severity of liver injury using methodology developed by the Drug-Induced Liver Injury Network (DILIN) study.

RESULTS:

 

Eight patients who developed liver injury after taking Hydroxycut treated at different medical centers were identified. All were hospitalized, and three of eight patients required liver transplantation. Nine other cases with adequate clinical information were obtained from the FDA MedWatch database, including one fatal case of acute liver failure. Usual symptoms were jaundice, fatigue, nausea, vomiting, and abdominal pain. Most patients exhibited a hepatocellular pattern of injury. Adjudication for causality revealed eight cases as definite, five highly likely, two probable, and two were considered to be possible.

CONCLUSIONS:

 

Hydroxycut has been clearly implicated as a cause for severe liver injury that may lead to acute liver failure and death. Weight-loss supplements represent a class of dietary supplements that should be regarded as capable of causing severe hepatic toxicity when the usual causes of identified liver injury cannot be otherwise elucidated.