The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli.
Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) 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 Xenical and Alli 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.
Orlistat (marketed as Alli and Xenical): Labeling Change
FDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication.
Jun 1, 2010
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