Why was Bextra withdrawn from the market?
The FDA concluded that Bextra has an increased risk of cardiovascular events with long-term use. This conclusion is strongly supported by the significant increase in cardiovascular risk seen in those patients who had just undergone heart surgery and the fact that other COX-2 selective NSAIDs have demonstrated such increased cardiovascular risk in long-term studies. In addition, Bextra already carries a boxed warning related to its increased risk of serious, life-threatening skin reactions, which have been reported at a much higher rate than for other COX-2 selective inhibitors. Finally, there are no data to suggest that Bextra has benefits that would outweigh these risks. Bextra has not been shown to offer any advantages over other existing NSAIDs. Therefore, the FDA concluded that the overall risk versus benefit profile of Bextra is unfavorable.
