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Bextra, a prescription pain management drug prescribed for patients suffering arthritis, needing acute pain management, or who suffer severe menstrual symptoms, is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
The Food & Drug Administration recently asked Pfizer, the drug's maker to withdraw the product from the marketplace.
The FDA said the health risks associated with Bextra outweigh the drug's benefits. They concluded that Bextra has an increased risk of cardiovascular (CV) events with long-term use. Their conclusion is supported by the significant rise in CV risk seen in patients who had recently undergone heart surgery.
FDA has also requested Pfizer to include a boxed warning in the Celebrex (celecoxib) label and manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use.
Bextra first gained FDA approval in November 2001. An estimated 7 million patients worldwide have taken Bextra with 12.9 million prescriptions written last year.
Studies have shown an increased risk of heart attacks, strokes and other cardiovascular events in patients taking Bextra. Additionally, the FDA has cited an increased risk for gastrointestinal bleeding and life threatening skin reactions, including Stevens Johnson Syndrome (SJS). |
