Though you may not have realized it, there’s a good chance that a doctor has prescribed you a medication for a use other than what it was approved for. This off-label use is perfectly legal, but isn’t as safe as it might be, in part because incentives to invest in costly clinical trials to test such uses are weak.
One out of five prescriptions is off-label. Some drugs, like those for cardiac conditions and anticonvulsants, are used off-label at a much higher rate. One study found that an average drug is used for 18 different conditions.
But the vast majority of off-label use lacks strong evidence of safety and effectiveness. The monetary incentives to invest in costly clinical trials to demonstrate them are weak. So it’s not a surprise that off-label use is associated with a 44 percent greater risk of having an adverse event or side effect than with on-label use, according to a recent study. Side effects can be as mild as dry mouth or as severe as heart rhythm abnormalities.
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