FDA Adds Severe Liver Injury Warnings to Weight-Loss Drugs Xenical, Alli

May 27, 2010, 08:05 am

On May 26, 2010, the Food and Drug Administration (FDA) announced an approval of new labeling on Xenical (orlistat), a popular prescription weight loss medication marketed by Roche, and Alli, the over-the-counter version of orlistat, marketed by GlaxoSmithKline. The new labeling will include additional safety warnings concerning the risk of severe liver injury that can occur in rare cases with the medications.

Though no incidences of liver problems were reported during pre-approval clinical trials of the medications, post-marketing adverse event reports submitted to the FDA have identified severe liver injury as a possible safety concern. The agency has since reviewed 13 cases of severe liver injury, including two patient deaths from liver failure and three patients who required a liver transplant. The majority of the cases of liver injury occurred with Xenical.

Patients taking Xenical or Alli should discontinue use of the medications at the first indication of liver complications. Symptoms of liver damage or injury may include itching, yellowing of the skin or the whites of the eyes (jaundice), dark urine, light- or clay-colored stools, or a loss of appetite.

An estimated 40 million people worldwide have used either Xenical or Alli for weight loss. Both medications contain the active ingredient orlistat and are used for obesity management in combination with a reduced-calorie and low-fat diet.

Additional information about drugs and drug side effects may be found on DrugWatch.com.

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