BEXTRA
Bextra is manufactured by Pfizer, Inc. It is a widely prescribed prescription arthritis pain medication in the United States. It is part of a class of pain medications known as Cox-2 inhibitors, of which there are three in total:
- Vioxx - withrawn from the market on September, 2004
- Celebrex
- Bextra
On December 9, 2004, the Food and Drug Administration (FDA) announced that a "black box" warning needed to be placed on all packages and labels of Bextra. The new boxed warning in the label stated that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysys. In addition, the label warnings also highlighted new data on cardiovascular risks. Observed cardiovascular events in a study conducted by Pfizer included:
- Myocardial infarction (heart attack)
- Cerebrovascular accident (stroke)
- Deep vein thrombosis (blood clots in the leg)
- Pulmonary embolism (blood clot in the lung)
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On April 7, 2005, the FDA asked Pfizer, Inc. to withraw Bextra from the market.