The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc. 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, 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, stomach or abdominal pain, 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 professionals 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, energy-enhancers, 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.

Why are these products being recalled?

Hydroxycut products have been associated with potential risk of severe liver injury. The FDA has learned of several other serious problems that some Hydroxycut users have had, including seizures; rhabdomyolysis and cardiovascular problems, ranging in severity from irregular heart beat to heart attack.

What are the symptoms I should watch for if I have taken Hydroxycut?

Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms of liver disease might include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, or loss of appetite.

Are some people at higher risk than others?

There is not sufficient medical evidence at this time to make a definitive statement on the risk of one segment of the population over another. It is, however, important to note that even people who had no pre-existing medical conditions have needed liver transplants after taking Hydroxycut.

If I were going to have symptoms, how soon would they appear?

Symptoms could have occurred while you were taking Hydroxycut, or they could occur up to several months after you stopped taking it.