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Drug safety on trial. Last year's withdrawal of the anti-arthritis drug Vioxx triggered a debate about how to better monitor drug safety even after approval.

In September last year, Merck (Whitehouse Station, NJ, USA) withdrew its anti-arthritis blockbuster drug Vioxx® (rofecoxib) after studies showed that it increases the risk of myocardial infarctions and strokes. Vioxx is, however, only the latest in a long series of highprofile drug withdrawals. Over the past few years, pharmaceutical companies voluntarily withdrew the lipid-lowering drug Lipobay® (Baycol®; cerivastatin), the anti-obesity drugs fenfluramine and dexfenfluramine, and several other medicines due to safety concerns. And that may not be the end; according to an official with the US Food and Drug Administration (FDA), there are even more drugs on the market that should be withdrawn for safety reasons. The Vioxx case has already led to a storm of criticism from members of the US Congress, medical journals and even from within the FDA, and fuelled fierce debate about how to reorganize the agency’s monitoring of approved drugs so as to prevent similar cases (Harris, 2004; Frantz, 2005). As the dust from the withdrawal of Vioxx began to settle, one thing became clear. The views of society regarding the balance between the risks and benefits of medicines has shifted, something that pharmaceutical companies, regulators and scientists need to face. This underlies the increasing emphasis on drug safety, and addressing these growing concerns probably requires changes on several fronts. Drug safety agencies may need legally enforceable phase IV studies— performed once a drug reaches the market—to follow a drug’s safety and efficacy after approval. Some commentators believe that new drugs should also be granted a probationary licence that is confirmed only if post-marketing studies show an acceptable risk–benefit profile. In addition, clinicians and doctors in private practice should become more proactive in reporting adverse events while pharmaco-epidemiologists need to collate data on drug performance from diverse sources.