FDA TO REQUIRE EVALUATION OF CELEBREX, BEXTRA STUDIES

The FDA has announced that it is requiring evaluation of all prevention studies involving Celebrex and Bextra to ensure that adequate precautions are implemented in the studies and instructing institutional review boards to reevaluate them in the wake of recent evidence that the compounds may cause increased cardiac risk.

The agency also issued a public health advisory instructing physicians who are considering prescribing Pfizer's arthritis drugs Celebrex (celecoxib) or Bextra (valdecoxib) to consider the emerging evidence when weighing the risks versus the benefits of prescribing the medicines to patients.

The FDA action comes in the wake of a series of disclosures stating that some studies have revealed an increased risk of heart attack and stroke connected with the use of Cox-2 inhibitors over long periods of time or immediately after heart surgery.