Editor's Notes:

While the media have battened onto the Cox-2 painkiller Vioxx as an example of everything that is wrong with the FDA, they have largely overlooked the fact that some painkillers in common use—and commonly considered safe—may also have rare side effects that pose similar risks to Vioxx. The British Medical Journal, for instance, recently published a study finding that:

Ibuprofen and other commonly used painkillers for treating inflammation may increase the risk of heart attack…

Researchers found that for those prescribed NSAIDs in the three months just before the heart attack, the risk increased compared with those who had not taken these drugs in the previous three years. For ibuprofen, the risk increased by almost a quarter (24%), and for diclofenac it rose by more than half (55%).

The newer generations of anti-inflammatories—Cox-2 inhibitors—also were associated with increased rates of first-time heart attack. Those prescribed the drugs in the preceding three months were at 21% higher risk of heart attack if taking celecoxib, and 32% increased risk if taking rofecoxib.

This finding is significant because after Vioxx and another COX-2 drug, Bextra, were withdrawn from the market, patients have shifted to the older NSAID painkillers, assuming that they posed less risk. That may yet turn out to be true. But in the interim, we shouldn’t allow rare risks to create knee-jerk reactions to medicines—old or new—that are extremely useful and safe for the vast majority of patients.