Why was Bextra removed from the market?
On April 7, 2005, the FDA requested that Pfizer withdraw Bextra® (valdecoxib) from the market (for further information, click here). Pfizer responded that it “respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA.” (for further information, click here). The FDA is also asking that all prescription NSAIDs (non-steroidal anti-inflammatory drugs), including the COX-2 inhibitor Celebrex (celecoxib), a COX-2 selective NSAID, revise the package insert and include a “black box” warning about possible cardiovascular events with these drugs (in addition to risks of gastrointestinal bleeding). Over-the counter NSAID’s (other than aspirin) are also being asked to add these risks to their labeling. The FDA stated that they have requested the voluntary withdrawal of Bextra® because they decided that the risks of the
