Xenical/Alli May Cause Liver Damage

Orlistat, the generic name for the active ingredient in the medications Xenical and Alli, has been indirectly linked to severe liver damage in thirteen individual cases, according to the U.S. Food and Drug Administration (FDA) May 26, 2010. Twelve of the reported cases were from individuals outside of the U.S. who were taking Xenical; one of the reported cases of severe liver damage was from an individual in the U.S. who was taking Alli.

The FDA is now requiring both Xenical and Alli to add a warning about the potential for severe liver damage in rare cases to the labels of the products. Some of the liver damage incurred by the thirteen individuals was severe enough to require a liver transplant or resulted in death due to "hepatocellular necrosis [liver cell death] or acute hepatic failure [liver failure]" (www.fda.gov).

Orlistat

Xenical is the prescription-strength form of orlistat, containing 120 milligrams of the ingredient in each tablet. Alli is the over-the-counter strength form of orlistat, containing 60 milligrams of the ingredient in each tablet.

U.S. Food and Drug Administration Safety Review Results

This information was originally released in August 2009 by the FDA when it had completed its safety review of orlistat, including all available information from April 1999 through August 7, 2009 (www.medscape.com) The review included preclinical and clinical trial data, postmarketing studies and drug utilization information.

Orlistat is being indirectly linked to the liver damage because although all thirteen individuals were taking the medication, it has not been established that the orlistat caused the individuals' liver problems. According to the FDA there are three main reasons why the usage of orlistat cannot be conclusively determined to be the causative factor in the reported liver damage: 1) In the ten-year study period, only thirteen individuals out of 40 million users worldwide developed liver problems 2) Some of the thirteen individuals were taking other drugs or had other conditions which may factor into the development of liver damage 3) It is possible for people to develop severe liver damage without taking drugs or any other known cause.

Consumer Alert

Even though no direct link has been determined between the rare instances of severe liver damage and the use of orlistat products, consumers should be aware of the risks and weigh the need for the use of the medication, whether prescription strength or over-the-counter strength, before beginning to take the medication or to continue its use.

For those individuals taking orlistat, be aware of the signs/symptoms of liver problems such as yellowing of the skin and/or whites of the eyes, itching, loss of appetite, light-colored or white stools, pain or swelling near or beneath lower right rib cage area, or dark urine. Report these symptoms to your health care professional as soon as possible.

Sources: Medscape
U.S. Food and Drug Administration
MSNBC