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. One death due to liver failure has been reported to the FDA. 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.
The FDA urges consumers to stop using Hydroxycut products in order to avoid any undue risk, says Linda Katz, M.D., interim chief medical officer of FDA's Center for Food Safety and Applied Nutrition.
"Adverse events are rare, but exist," Katz says. "Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.
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
Consumers who have these products are advised to stop using them and to return them to the place of purchase.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to 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
