Xenical and Alli: Weight-Loss Drugs Under FDA Investigation for Link to Liver Failure, Liver Disease

Xenical and Alli, two forms of the popular weight-loss drug orlistat, are now being investigated by the Food and Drug Administration after dozens of reports of users developing liver failure or liver disease.

Xenical is the prescription-strength form of orlistat made by Roche and approved by the Food and Drug Administration in 1999. Alli, made by Roche, is the lower-dose over-the-counter version of orlistat made by GlaxoSmithKline and approved for use in the United States in 2007.

Both drugs are now under investigation for a link to liver failure and liver disease in dozens of users. From 1999 through October 2008, the FDA said it received 32 such reports from users of the two drugs, including six cases of liver failure and 27 cases in which patients required hospital treatment.

The drugs are commonly used in conjunction with reduced-calorie and low-fat diets by patients who have lost weight and want to avoid gaining it back. They differ from most weight-loss drugs, which either boost metabolism or suppress appetite. Alli and Xenical work by preventing the digestive system from absorbing dietary fat, which reduces daily caloric intake and limits weight gain.

Liver Failure, Liver Disease Risks

Liver failure is a serious medical condition in which the liver cannot perform its normal functioning. The disease can develop suddenly (acute liver failure) or over time (chronic liver failure). Acute liver failure may result in confusion, stupor, and coma as well as decreased production of blood proteins. Chronic liver failure typically is caused by increased alcohol intake, hepatitis B or C, or a variety of autoimmune, hereditary and metabolic causes.

Liver disease, also called hepatic disease, is the medical term used to describe a broad category of diseases including hepatitis, cirrhosis, and non-alcoholic fatty liver disease, among others.

In addition to liver failure and liver disease, Alli and Xenical have been associated with severe side effects, such as jaundice, abdominal pain, nausea, vomiting, light-colored stools, brown or dark yellow urine, itching, and loss of appetite.

While the FDA is investigating whether Alli and Xenical cause liver failure and liver disease, patients who are taking orlistat in either form are not being advised to stop doing so. Consumers should continue to take the drugs as directed unless otherwise instructed by their physicians, the FDA said.

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