On May 1, 2009 the US Food and Drug Administration (FDA) issued a warning of possible liver damage resulting in death that has been linked to the use of the diet aid Hydroxycut. Reports linked use of the popular diet aid to at least one death and dozens of serious health problems including jaundice and elevated liver enzymes, an early sign of potential liver damage. Several patients experienced liver failure. Some survived as a result of liver transplant. One died when his liver transplant was aborted following the discovery of additional serious health complications. The FDA has said that everyone should stop using this potentially dangerous diet aid manufactured by Iovate Health Sciences, Inc. If you have unused Hydroxycut, you should return it to the place of purchase.

Those affected were healthy before they began taking Hydroxycut, and most had no risk factors for liver damage. The user who died was a 20-year old male. He died in 2007, but the link to Hydroxycut was not reported to the FDA until this March.

If you have been using Hydroxycut, you should look out for the signs of liver damage, including:

Jaundice
Brown urine
Nausea
Vomiting
Pale stools
Fatigue, weakness
Stomach pain and loss of appetite

If you experienced these symptoms after using Hydroxycut, you should consult your doctor about possible liver damage. The FDA does not yet know what ingredient or ingredients may be responsible for the liver damage.

Diet aids are not strongly regulated by the FDA. Prescription medications undergo premarket approval to verify their safety and effectiveness, but diet aids and nutrition supplements are exempt from this requirement. Manufacturers of diet aids like Hydroxycut do not have to prove that their products are effective or even safe, and the FDA does not verify that the ingredients listed are the only ones present. Although this type of product often claims to be all-natural to imply it is safe, many of them are as dangerous as prescription drugs, but without FDA oversight. It is only after reports of serious injury that the FDA begins action, and even then it can rarely force a product recall, only request one. In the case of Hydroxycut, Iovate Health Sciences, Inc. announced a voluntary recall “out of an abundance of caution.” The FDA’s list of recalled Hydroxycut products lists all 14 varieties being recalled. The recall of Hydroxycut follows warnings of other diet aids like Fen-Phen and PPA.

If you have been injured as a result of a dangerous drug, whether FDA-approved or without premarket approval, please talk to a Columbus, Ohio product liability lawyer at the offices of Robert W. Kerpsack Co., L.P.A..