I Didn’t Know That...

Q: What are “off-label” uses of drugs?

A: When the Food and Drug Administration approves the marketing of a drug, that approval is for treating a specific disease. Once a drug is on the market, however, physicians are free to prescribe the drug for any purpose they deem reasonable--but drug companies are not free to promote such use. Amitriptyline, for example, is approved for treatment of depression, but physicians frequently prescribe it “off-label” for the prevention of migraine headaches. Research on a drug often continues after its approval, and it is not unusual for the FDA to grant approval for secondary uses, thereby allowing companies to market for those purposes as well.