Bextra Recall

In April 2005 the FDA requested Pfizer Inc. withdraw Bextra from the marketplace. The FDA aske for this Bextra recall after determining the overall-risk-versus-benefit profile is "unfavorable."

This FDA recall request of Bextra is based on:

• Little information on the cardiovascular safety of long-term use of Bextra, and the increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery trials.
• Many reports of serious and potentially life-threatening skin reactions in patients using Bextra. The reaction risk is unpredictable.
• Little or no distinct advantages of Bextra over other NSAIDs.

After making the Bextra recall request, the FDA said patients now taking Bextra should contact their physicians for other treatments.

In a Bextra recall statement, the FDA asked manufacturers of all prescription non-steroidal anti-inflammatory drugs (NSAID) to rewrite package labeling to include a boxed warning and Medication Guide.

All manufacturers of non-prescription NSAIDs were also requested that they revise their labels to include specific information about the potential GI and CV risks. Information to help consumers safely use the drug must also be included.

Aspirin was not part of the Bextra recall since it reduces the risk of serious adverse CV events in certain patients.