Off label medication use may attract a higher risk of adverse drug events

Off-label use of medicines is thought to contribute to preventable adverse drug events (ADEs) in children. A recent study published by the JAMA network has examined this issue in a population of over 46,000 adults who were treated with 151 305 incident prescribed drugs in Canada. 3484 ADEs were seen, with an incidence rate of 13.2 per 10 000 person-months. The rate of ADEs for off-label use (19.7 per 10 000 person-months) was higher than that for on-label use (12.5 per 10 000 person-months) (adjusted hazard ratio [AHR], 1.44; 95% CI, 1.30-1.60). Off-label use lacking strong scientific evidence had a higher ADE rate (21.7 per 10 000 person-months) compared with on-label use (AHR, 1.54; 95% CI, 1.37-1.72), but off-label use with strong scientific evidence had the same risk for ADEs as on-label use (AHR, 1.10; 95% CI, 0.88-1.38). The risks were  higher for older drugs.