Hydroxycut Recalled After FDA Liver Warnings

WASHINGTONAfter receiving 23 serious adverse event reports including jaundice, elevated liver enzymes and liver damage requiring transplant, as well as one death due to liver failure, FDA has warned the public against using a number of popular Hydroxycut weight-loss products, which the manufacturer has voluntarily recalled.

FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist," said Linda Katz, M.D., interim chief medical officer, FDA Center for Food Safety and Applied Nutrition (CFSAN). "Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products."

FDA noted the reports of liver injury, which is considered a rare side effect, came from patients taking doses recommended on the Hydroxycut bottle. Primary symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine; other symptoms can include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.

Other health problems reported to FDA include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Hydroxycut is distributed by Iovate Health Sciences USA, based in Blasdell, N.Y., but made by Iovate Health Sciences Inc., Oakville, Ontario, which agreed to recall many Hydroxycut products from the market. Although FDA had not received such serious adverse reaction reports (AERs) for all Hydroxycut products, Iovate has agreed to recall the following products (sold under both Iovate and MuscleTech brands):

Hydroxycut Cleanse and Hoodia products are not affected by the recall.

FDA advised consumers who have any of the products involved in the recall to stop using them and to return them to the place of purchase. The agency further asked health care professionals and consumers 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.

The agency has not yet determined which ingredients, dosages or other factors may be associated with the liver problems, but it continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

In addition to issuing the voluntary recall of Hydroxycut products, Iovate published a special Web page to provide consumers with detailed information on Hydroxycut products involved in the recall, as well as some details on Iovate's quality control and safety protocols.

"We conduct internal analyses of individual ingredients and undertake extensive medical, scientific and toxicological literature reviews on the safety of the ingredients during the development stage of each product," the company assured. "Additionally, third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovates ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula."

The Council for Responsible Nutrition (CRN) said both FDA and the Hydroxycut maker took approriate action in response to this situation. Steve Mister, president and CEO of CRN, noted the potential safety problem was revealed by an effective adverse event reporting (AER) system recently implemented for dietary supplements, which are regualted by both FDA and FTC. "It should be noted that adverse events do not establish causality, nor is enough known at this point to determine whether the adverse events associated with these products were idiosyncratic, dose-related, ingredient-related or simply random," he said.