| U.S. Food and Drug Administration |
FDA Press Release, May 1, 2009
FDA Warns Consumers to Stop Using Hydroxycut Products
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury
The U.S. Food and Drug Administration is warning 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, N.Y.
Some Hydroxycut products are associated with a number of serious liver injuries.
Iovate has agreed to recall Hydroxycut products from the market.
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.
Liver injury, although rare, was reported by patients at the doses of
Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice
(yellowing of the skin or whites of the eyes) and brown urine. 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. 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.
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. 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
Although the FDA has not 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. 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
agency has not yet determined which ingredients, dosages, or other
health-related factors may be associated with risks related to these Hydroxycut
products. The products contain a variety of ingredients and herbal extracts.
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 the FDA's MedWatch Adverse Event Reporting program by fax or phone.
– Fax: 800-FDA-0178
– Phone: 800-FDA-1088
The FDA continues to investigate the potential relationship between
Hydroxycut dietary supplements and liver injury or other potentially serious
side effects.
This advisory was prepared by the FDA Office of Public Affairs.