Special Alerts:

[Posted 05/26/2010] FDA notified healthcare professionals and patients that it has approved a revised label for orlistat (Xenical) to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for orlistat (Alli).

Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Orlistat 120 mg (Xenical) is available by prescription and orlistat 60 mg (Alli) is sold over-the-counter without a prescription. This new safety information, originally announced in August 2009, is based on FDA’s completed review of orlistat.

Healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with orlistat before prescribing or recommending these medications to their patients; patients should stop use of orlistat and contact their healthcare professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite. For more information visit the FDA website at: [Web] and [Web].

FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat (Xenical, Alli). Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA’s MedWatch Adverse Event Reporting program at: [Web]. For more information visit the FDA website at: [Web] and [Web].