Bextra and the FDA

In early 2005, Pfizer stopped selling Bextra over concerns about Bextra's link to rare, life-threatening skin reactions. These concerns are not new. The FDA required Pfizer to add a black-box warning about them to Bextra's label in early December. At the same time, the FDA also required that Pfizer add information to Bextra's label to highlight new data about heart-attack and stroke risk. A recently completed study had found an increased cardiovascular risk in patients who had received Bextra after undergoing bypass surgery, compared with those who had received a placebo.