FDA Adds Severe Liver Injury Reports To Labels of Two Weight Loss Drugs

The Food and Drug Administration May 26 announced that it has approved a revised label for the weight loss drug Xenical to include new safety information about rare cases of severe liver injury with the use of this medication.

The agency said it also is adding a new warning about rare reports of severe liver injury to the over-the counter 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 is manufactured by Roche Pharmaceuticals, while Alli is manufactured by GlaxoSmithKline.

This new safety information is ...