Off-label prescribing has been under scrutiny since a recent study found that medications prescribed for non-FDA-approved uses are associated with a significantly higher rate of negative side effects.
It is estimated that up to 20% of all medications prescribed are for indications that are not approved by the FDA.
In the study, which was published in JAMA Internal Medicine, the rate of side effects for off-label drugs was 44% higher than on-label ones.
Although there is sometimes strong scientific evidence to support an off-label use, the study found that about 80% of the examined off-label prescriptions were not supported by strong scientific evidence. Most common among them were antidepressants, antipsychotics, and anticonvulsants.