Experts Point to Lessons Learned From Controversy Over Rofecoxib Safety

摘要

Chicago-Now that rofecoxib has been pulled from the market due to life-threatening adverse cardiovascular events, which had reportedly been evident 4 years ago, patients and physicians are left with many questions regarding the safety of other drugs that preferentially inhibit the cyclooxygen-ase-2 (COX-2) enzyme and the shortcomings in the government's drug monitoring system in general.Researchers and clinicians met here at the annual conference of the Osteoarthritis Research Society International in December to discuss the issues and to look at what should be done to safeguard patients.Daniel Solomon, , MPH, of Brigham and Women's Hospital, in Boston, said he hopes the incident leads to the development of an improved drug safety system. "I think when safety concerns arise prior to drug approval, which they did for the rofecoxib incident, we need to require adequately powered trials before a drug is approved."In today's environment, with the Food and Drug Administration (FDA) under pressure to provideaccelerated review for pharmaceutical drugs, randomized controlled clinical trials are often not thorough enough to ensure safety for all patients, Solomon noted. But such trials are not the only potentially useful source of information about a drug's safety.