FDA Asks Pfizer to Withdraw Bextra From Market

The Food and Drug Administration has asked Pfizer to withdraw Bextra from the market “because the overall risk versus benefit profile for the drug is unfavorable.” Pfizer has agreed to do so pending further discussions with the agency. Here is a the FDA press release.

The press release goes on to say that the “FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs.” Celebrex is being allowed to stay on the market with revised labels.

This probably means that the FDA will not allow Vioxx back on the market. I will keep you updated.