"In the wake of Merck's voluntary, worldwide withdrawal of rofecoxib (Vioxx) on Sept. 30, concerns are surfacing over whether the adverse cardiovascular risk documented with rofecoxib may be a class effect extending to the other cyclooxygenase-2 (COX-2) inhibitors. The U.S. Food and Drug Administration (FDA) issued a public health advisory to inform patients about the withdrawal of rofecoxib, and Acting Commissioner Lester M. Crawford announced the FDA's intention to closely monitor other COX-2 inhibitors for similar adverse events."
Pfizer's drug valdecoxib (Bextra) is also "under a cloud because another FDA physician reviewing the data on that drug concluded there may be an increased cardiovascular risk," said Dr. Wolfe, who is also an adjunct professor of internal medicine at Case Western Reserve University in Cleveland, Ohio. "I think it is very likely that the effect of increasing cardiovascular risk is a class effect." According to agency files obtained in a lawsuit by Public Citizen, an unredacted review by the FDA Medical Officer recommended nonapproval for valdecoxib for acute pain, citing the Coronary Artery Bypass Graft (CABG) Surgery study 035. Even though the entire study population received prophylactic low-dose aspirin, this trial showed an excess of serious cardiovascular thromboembolic adverse events including death in association with the use of valdecoxib, 40 mg twice daily, when added to ad lib parenteral narcotic analgesia. In other databases, including formal safety Trials 47 and 62, valdecoxib at doses higher than 20 mg per day was associated with a greater incidence of edema and hypertension than were ibuprofen, naproxen, and diclofenac.