FDA MedWatch - 2009 Safety Alerts for Human Medical Products

Hydroxycut Products
Audience: Consumers, healthcare professionals
[Posted 05/01/2009] FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc., because they are associated with serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplants. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

[May 01, 2009 - Hydroxycut Products page - FDA]
[May 01, 2009 - News Release - FDA]
[May 01, 2009 - Dear Healthcare Professional letter - FDA]
[May 01, 2009 - Consumer Questions and Answers - FDA]
[May 01, 2009 - Health Hazard Evaluation - FDA]

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FDA MedWatch - 2009 Safety Alerts for Human Medical Products