FDA Recalls Dietary Supplements Tied to 1 Death, Liver DamageLast Updated: May 01, 2009. Hydroxycut products are sold as fat-burners, energy boosters, agency says.
By Amanda Gardner
FRIDAY, May 1 (HealthDay News) -- U.S. health officials are warning consumers to stay away from Hydroxycut dietary supplement products marketed under the Iovate and MuscleTech brand names because of reports of liver problems resulting in at least one death -- an otherwise healthy 19-year-old male.
The manufacturer of the products, sold as fat burners and energy-boosters, is voluntarily recalling 14 products from the market.
"Consumers are advised to discontinue use of Hydroxycut products and consult a physician or health care professional if they are experiencing any symptoms of liver injury, which can include jaundice and brown urine, nausea, vomiting as well as unusual tiredness, unexplained itching and loss of appetite," said Dr. Linda Katz, interim chief medical officer at the Center for Food Safety and Applied Nutrition (CFSAN), part of the U.S. Food and Drug Administration (FDA), at a Friday news conference.
"Although liver damage appears to be rare, FDA feels consumers should not be exposed to unnecessary risk," Katz added.
The agency has received 23 reports of adverse liver effects including jaundice and liver damage severe enough to require organ transplant. Other individuals have experienced seizures, cardiovascular and other health problems. The medical literature also contains reports of liver issues in six patients taking Hydroxycut products.
Authorities do not yet know which ingredients are specifically associated with the problems.
The products being recalled are:
- 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
Iovate Health Sciences of Oakville, Ontario, Canada has agreed to recall all the products. The company reports that more than 9 million units of Hydroxycut products were sold in 2008 in health food stores, grocery stores and pharmacies.
"They are widespread," said Vasilios Frankos, division director of the Office of Dietary Supplement Programs, CFSAN, FDA.
Hydroxycut Cleanse and Hoodia products are not being recalled as they have no overlapping ingredients with the 14 other products.
For more on Hydroxycut products, visit the FDA.
SOURCES: May 1, 2009 teleconference with Linda Katz, M.D., interim chief medical officer, Center for Food Safety and Applied Nutrition (CFSAN), FDA, and Vasilios Frankos, Ph.D., division director, Office of Dietary Supplement Programs, CFSAN, FDA
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