The FDA has notified healthcare professionals and patients that it has approved revised labeling for Xenical (orlistat, from Roche) and Alli (orlistat, from GlaxoSmithKline) to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. At this time, a cause and effect relationship of severe liver injury with orlistat has not been established. The FDA has added this information to the product labeling due to the seriousness of severe liver injury.
Xenical and Alli are used for the management of weight-loss as an adjunct to diet in overweight and obese patients. Xenical (orlistat 120mg) is available by prescription and Alli (orlistat 60mg) is available over-the-counter without a prescription. Healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with Xenical and Alli before prescribing or recommending these medications to their patients; patients should stop using orlistat and contact their healthcare provider if they develop signs and symptoms of liver injury (eg, itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite).
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213448.htm.