Safety in Numbers — Monitoring Risk in Approved Drugs

Abstract

In most cases, when a new drug is approved, almost everything known about its safety in humans is based on the responses of a few thousand people who took it during clinical trials. But once the drug is on the market, the real safety testing gets under way. Within a year or two, the number of people who are exposed to the medication may climb into the millions, especially if the manufacturer promotes it aggressively with television or print advertisements that target consumers. If the drug has a dangerous but rare side effect — for example, liver failure or aplastic . . .