Why isn’t FDA requesting that Celebrex also be withdrawn?
The Advisory Committees were unanimous in their conclusion that an increased risk of CV 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 CV 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 CV and GI risks will be applied to Celebrex, and in addition the labeling will include additional information as described in question 2 above that will inform physicians and patients
