FDA's MedWatch Safety Alerts: June 2009
FDA Warns Consumers to Immediately Stop Using Dietary Supplements Labeled Hydroxycut Because of the Potential Risk of Severe Liver Injury
Hydroxycut products are distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Iovate has agreed to recall Hydroxycut products from the market.
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.
The recalled products include:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Caplets
- Hydroxycut Max Liquid Caplets
- Hydroxycut Regular Drink Packets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Natural
- Hydroxycut Cleanse and Hoodia products are not affected by the recall
Adverse events: FDA has received 23 reports of serious health problems ranging from jaundice (yellowing of the skin or whites of the eyes) and elevated liver enzymes (an indicator of potential liver injury), to liver damage requiring a liver transplant and one death due to liver failure.
Other health problems reported include seizures, cardiovascular problems, and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
People at risk: Anyone who has taken any of the recalled Hydroxycut products, even if they haven't exceeded the doses recommended on the bottle.
Recommendations:
- Stop using the recalled products and return them to the place of purchase.
- Watch for symptoms of liver injury including jaundice and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
- Call your health care professional if you have symptoms possibly associated with these products.
- FDA actions: FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.
For more information:
FDA's Web Page on Hydroxycut Products at www.fda.gov/ForConsumers/ConsumerUpdates/ucm152152.htm
Source: U.S. Food and Drug Administration at http://www.fda.gov/ForConsumers/default.htm

















