Why didn the FDA also recommend that Celebrex be withdrawn?
The FDA stated: “The Advisory Committees were unanimous in their conclusion that an increased risk of cardio-vascular adverse events has been demonstrated for Celebrex (as for all the Cox-2 selective inhibitors) but strongly supported the continued marketing of the drug. FDA has concluded, based on the available data, that the benefits of Celebrex outweigh its potential risks in properly selected and informed patients. This conclusion is based on our review of the available safety data and the long-term controlled clinical trial comparisons of Celebrex to non-selective NSAIDs. While it appears that Celebrex is associated with an increased risk of serious cardio-vascular adverse events, the available data do not support a conclusion that Celebrex is significantly worse than the non-selective NSAIDs. The NSAID class boxed warning regarding increased cardio-vascular and gastrointestinal risks will be applied to Celebrex, and in addition the labeling will include additional information as
