FDA approves revised safety label for Xenical

BETHESDA, Md. The Food and Drug Administration on Wednesday 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 the medication.

The agency also is adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for GlaxoSmithKline’s 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.