FDA Links Hydroxycut Weight Loss Supplements to Liver Damage
Manufacturer Recalls More Than a Dozen Products
By News Staff
5/6/2009
The FDA is warning consumers to stop using many Hydroxycut weight loss products because they can cause liver and other serious health problems, possibly leading to death.
According to Linda Katz, M.D., M.P.H., interim chief medical officer with the FDA's Center for Food Safety and Applied Nutrition, the agency has received 23 reports of adverse events in users of these Hydroxycut products, including asymptomatic liver enzyme changes, jaundice, liver damage requiring liver transplant and liver failure resulting in one death.
Katz said several additional cases of liver failure resolved when patients stopped taking Hydroxycut.
In conjunction with the FDA warning, Iovate Health Sciences Inc., of Oakville, Ontario, and Iovate Health Sciences USA Inc. of Blasdell, N.Y., makers of Hydroxycut products, announced a recall of more than a dozen of the weight loss products from the market.
"Although the liver damage appears to be relatively rare, FDA contends the consumer should not be exposed to unnecessary risk," Katz said. "FDA continues to investigate the potential relationship between the use of Hydroxycut dietary supplements and liver injury and other potentially serious side effects."
Katz said the FDA has not determined which Hydroxycut ingredient dosages may be associated with the risk of developing liver disease. She said there were overlapping ingredients in the recalled products, but no single ingredient was common to all the products.
The FDA is advising consumers to discontinue use of Hydroxycut weight loss products and to consult a physician if they are experiencing any symptoms of liver injury, including jaundice, brown urine, nausea, vomiting, light colored stools, unusual tiredness, weakness, stomach or abdominal pain, unexplained itching, and loss of appetite. Other health problems related to the use of Hydroxycut products reported to the FDA include seizures, cardiovascular disorders and rhabdomyolysis.
Physicians or patients should report any adverse events associated with the use of dietary supplements to the FDA's MedWatch Program online or by calling (800) 332-1088.
Hydroxycut's Cleanse and Hoodia products are not affected by the recall.
Katz said several additional cases of liver failure resolved when patients stopped taking Hydroxycut.
In conjunction with the FDA warning, Iovate Health Sciences Inc., of Oakville, Ontario, and Iovate Health Sciences USA Inc. of Blasdell, N.Y., makers of Hydroxycut products, announced a recall of more than a dozen of the weight loss products from the market.
"Although the liver damage appears to be relatively rare, FDA contends the consumer should not be exposed to unnecessary risk," Katz said. "FDA continues to investigate the potential relationship between the use of Hydroxycut dietary supplements and liver injury and other potentially serious side effects."
Katz said the FDA has not determined which Hydroxycut ingredient dosages may be associated with the risk of developing liver disease. She said there were overlapping ingredients in the recalled products, but no single ingredient was common to all the products.
The FDA is advising consumers to discontinue use of Hydroxycut weight loss products and to consult a physician if they are experiencing any symptoms of liver injury, including jaundice, brown urine, nausea, vomiting, light colored stools, unusual tiredness, weakness, stomach or abdominal pain, unexplained itching, and loss of appetite. Other health problems related to the use of Hydroxycut products reported to the FDA include seizures, cardiovascular disorders and rhabdomyolysis.
Physicians or patients should report any adverse events associated with the use of dietary supplements to the FDA's MedWatch Program online or by calling (800) 332-1088.
Hydroxycut's Cleanse and Hoodia products are not affected by the recall.
