Federal officials are calling for consumers to stop using a dietary supplement that has been linked to one death dn could pose the risk of liver injury.
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Ontario-based Iovate Health Sciences Inc. The product is distributed by New York-based Iovate Health Sciences USA Inc.
The FDA says some Hydroxycut products are associated with a number of serious liver injuries and that Iovate has agreed to recall Hydroxycut products from the market.
The FDA says it 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 transplant.
One death due to liver failure has been reported to the FDA, officials say.
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, according to FDA officials.
"The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk," said Linda Katz, M.D., interim chief medical officer of the FDA's Center for Food Safety and Applied Nutrition. "Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products."
The FDA says 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 list of products being recalled by Iovate currently includes:
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
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above.
Hydroxycut Cleanse and Hoodia products are not affected by the recall.
Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
Visit http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html for more information.
