Obesity Drug Labeling Updated with New Interaction, Side Effect

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xenical (orlistat; Genentech) regarding new drug interactions and adverse reaction updates to its labeling. Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet.

The product labeling has been updated to include a possible drug interaction with amiodarone. In a pharmacokinetic study where oral amiodarone was given during orlistat treatment, a reduction in exposure to amiodarone and its metabolite, desethylamiodarone, was seen; a reduced therapeutic effect of amiodarone is possible. The effects of initiating orlistat treatment in patients already stable on amiodarone therapy has not been studied.

Also, the labeling has been updated to include information describing rare postmarketing cases of orlistat-associated bullous leukocytoclastic vasculitis (LCV). Clinical signs of LCV include palpable purpura, maculopapular lesions, or bullous eruption.

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Xenical is a reversible inhibitor of gastrointestinal lipases that exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides.

Xenical is available as 120mg capsules in 90-count bottles.

For more information call (888) 835-2555 or visit Gene.com.

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