Harvard Health Letter

By the way, doctor: Why aren't drugs safe when they are approved?

Q. First it was Vioxx and now Avandia. Why can't doctors and the government screen out unsafe medicines?

A. The FDA requires testing for effectiveness and safety before it approves a drug. As citizens, we want the agency to thoroughly examine the safety of a drug before approving it, but we also want the FDA to move as quickly as possible to approve new medicines. You see the dilemma.

When a drug has a serious but rare side effect, very large studies may be needed to uncover it. Even then, sometimes side effects are discovered only after the drug is on the market, and many people have taken it. There's a great deal of interest in beefing up systems for post-approval surveillance of drugs so doctors and patients know about dangerous side effects as soon as possible.

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