FDA's COX-2 Safety Plan: Remove Bextra, Add "Black Box" To Celebrex
This article was originally published in The Pink Sheet Daily
Executive Summary
Pfizer has not yet agreed to withdraw Bextra but will suspend marketing pending further discussions with FDA. Boxed warning on all prescription NSAIDS – including Celebrex – will discuss increased cardiovascular and gastrointestinal risk. FDA's decision comes two days after Pfizer tells analysts COX-2 inhibitor sales are stabilizing.