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Bextra (valdecoxib) is one of three federally approved COX-2 inhibitors that have been used by millions of people worldwide as an arthritis painkiller. Merck & Co. pulled its COX-2 drug Vioxx from the market in September 2004 after an increased risk of heart attacks and strokes were discovered. Following the Vioxx recall, the safety of the remaining two COX-2 drugs, Pfizer Inc.’s Celebrex and Bextra, was also questioned.
In December 2004, data was released linking Celebrex to increased risk of cardiovascular events. By January 2005, data linking Bextra to increased risks for heart attacks and strokes suggested what many safety experts were already saying – that the cardiovascular events were a class wide effect. In a three-day FDA advisory panel meeting in February 2005, the committee ultimately voted to recommend Bextra remains on the market despite associated cardiovascular risks. The panel also recommended Bextra carry a strong warning, which will probably be included in the FDA’s most severe drug warning called a “black box” warning.
In mid-October 2004, Pfizer had sent out a letter to doctors warning them about the serious skin reaction called Stevens-Johnson syndrome, saying it will likely be added as a black box warning to the label. The letter notified doctors about the Bextra side effect, saying the severe skin rashes had led to hospitalizations and deaths.
