Does the FDAs request that Pfizer stop selling Bextra reflect new information about the drugs risks?
Concerns about Bextra’s link to rare, life-threatening skin reactions 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. Q: What should people who take Bextra do now? A: In statements Thursday, Pfizer and the FDA said patients should stop taking Bextra for now and talk to their doctors about treatment options. Q: What drugs have to carry the new warnings about heart attacks and strokes and serious skin reactions? A: The FDA’s new label requirements apply to a class of medications called non-steroidal anti-inflammatory drugs, or NSAIDs. The group includes COX-2 inhibitors, such as Vioxx, as well as old
