Severe Liver Injury with Orlistat (Xenical, Alli) (August 2010)

The labeling for the weight loss drug orlistat will include new safety information about rare cases of severe liver injury in patients taking this drug. Orlistat is sold by prescription as Xenical in 120 mg strength and over the counter as Alli in 60 mg strength. This action resulted from a recently completed FDA review that identified thirteen cases of severe liver injury with orlistat during an approximate ten-year period. One case in the United States involved Alli and twelve cases in foreign countries involved Xenical. During the same time period, an estimated 40 million people worldwide used Xenical or Alli. Although it has not been established that orlistat causes liver injury, patients should be told to contact their healthcare professional if they experience symptoms of liver dysfunction. These include itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite. If liver injury is suspected, clinicians should advise patients to stop taking orlistat immediately. Healthcare professionals and consumers should report adverse events with Xenical or Alli through FDA's MedWatch Program.