FDA warns consumers to stop using Hydroxycut dietary supplements
Consumers using Hydroxycut products should immediately stop taking the dietary supplements, the Food and Drug Administration warned today after receiving reports of serious health problems related to the drugs.
The dietary supplements -- made by Iovate Health Sciences Inc. of Oakville in Ontario, Canada, and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. -- have been linked to one death and are associated with several serious liver injuries, the FDA said. Iovate has agreed to recall the products from the market.
The FDA has received 23 reports of serious health problems including jaundice, elevated liver enzymes and liver damage requiring liver transplant. Other health problems reported included seizures, cardiovascular disorders and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
One death due to liver failure has been reported to the agency.
Liver injury was reported by patients taking the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice and brown urine, the FDA said. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk," said Linda Katz, 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 healthcare professional if they are experiencing symptoms possibly associated with these products."
Hydroxycut products are dietary supplements that are marketed for weight loss as fat burners, energy enhancers, low-carb diet aids and water loss. The list of products being recalled by Iovate 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 Carb Control
Although the FDA hasn't 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. (Some hoodia sellers on Monday were sued by the Federal Trade Commission on charges of deceptive advertising for claiming that their produce would help people lose weight.)
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 products contain a variety of ingredients and herbal extracts.
Healthcare professionals and consumers are encouraged to report serious side effects or product quality problems to the FDA's MedWatch Adverse Event Reporting program:
-- Online: www.fda.gov/MedWatch/report.htm
-- Regular mail: Use FDA postage-paid Form 3500 found at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-- Fax:( 800) FDA-0178
-- Phone: (800) FDA-1088
-- Andrea Chang
Photo: The FDA has linked the use of Hydroxycut products to serious health problems. Credit: www.bodyshapersfitness.com