Warning issued on Vioxx alternative Bextra

Since the recall of Vioxx, doctors in the United States have been prescribing two alternative drugs: Celebrex and Bextra. While conclusive evidence is not yet available if these two drugs are less dangerous than Vioxx, a recent study simply suggests that Vioxx was definitely more dangerous.

From today onwards, however, Bextra will come with a new warning. "FDA believes that, based on what we know now, the overall benefit of Bextra outweighs the risk when used in properly selected patients as directed in the approved labeling," the FDA said in a statement. A study of more than 1,500 heart surgery patients found people treated with Bextra for pain were more likely to have problems such as heart attacks, strokes and blood clots in the legs or lungs, the agency said.

The new label strengthened the warning about the possibility of serious skin reactions, including two types of reaction that can result in death (Steven-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN). It also added a new warning about possible heart and blood clotting problems, particularly in patients who have just had coronary artery bypass graft surgery (CABG)

FDA says that it will continue to monitor the side effects related to Bextra and take additional actions as appropriate. FDA continues, "As we have previously announced, FDA will also hold a public advisory committee meeting in February to discuss safety concerns of all marketed COX-2 and related drugs, including Bextra." (Related article: Vioxx recall focuses limelight on Cox-2 inhibitors)

FDA reports that other COX-2 selective NSAIDs and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but these serious side effects appear to occur more often for patients taking Bextra than for other COX-2 agents. Bextra can also cause stomach ulcers, burning pain in stomach, dark stools or blood in stool, vomit that looks like blood, rashes and other skin reactions, and chest pain.

In summary, what the FDA is telling Americans, who may be taking Bextra, is to think again and discuss their situation with their doctors.

Related article: Alternatives to Vioxx are not all totally safe

Source: FDA