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TOPIC: FDA issues warning on Hydroxycut-Stop using

FDA issues warning on Hydroxycut-Stop using 02 May 2009 10:02 #2987

  • Debra
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FDA issues warning to stop using Hydroxycut products

The U.S. Food and Drug Administration today warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, NY.   Some Hydroxycut products are associated with a number of serious liver injuries.

  The 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 transplant.  The Mandatory Adverse Event Reporting Act requires manufacturers to report any serious adverse event within 15 days of receipt.  According to FDA, the majority of the 23 reports are from voluntary sources and only a few were received from the company, which has agreed to recall Hydroxycut products from the market.   

  “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,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.   In addition, the FDA is issuing a ‘dear doctor’ letter asking alerting them to ask patients about supplement use if they exhibit specific symptoms.
 
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.  A complete list of products being recalled by Iovate can be found at
http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html

  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 FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects, as authorized by law. 

  To report serious adverse events (side effects) or product quality problems with the use of these products, go to the FDA's MedWatch Adverse Event Reporting program online:  http://www.fda.gov/MedWatch/report.htm
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