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 Bextra Recall
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 In April 2005 the FDA requested Pfizer Inc. to voluntarily withdraw Bextra (valdecoxib) from the marketplace. The FDA made this Bextra recall request after determining the overall-risk-versus-benefit profile is "unfavorable." |
This Bextra recall request by the FDA is based on the following:
- A dearth of adequate information on the cardiovascular (CV) safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery trials.
- The reporting of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of reactions is unpredictable. They occur in patients regardless of prior history of sulfa allergy, and after both short- and long-term use.
- No demonstrated advantages for Bextra compared with other NSAIDs.
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In making the Bextra recall request, the FDA advised patients currently taking Bextra to contact their physicians to consider other treatments.
The FDA, in the Bextra recall statement, also asked manufacturers of all prescription non-steroidal anti-inflammatory drugs (NSAID) to revise package labels to include a boxed warning and Medication Guide.
The boxed warning is to highlight the potential for increased risk of CV events with these drugs and the gastrointestinal (GI) bleeding associated with their use.
The Medication Guide is to accompany every prescription NSAID as it is dispensed to inform patients about the CV and GI risks.
The FDA has also asked manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug.
The Bextra recall announcement does not apply to aspirin since it has shown to reduce the risk of serious adverse CV events in certain patients. |
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