Off-label use of drugs in neonatal intensive care units.

Objective: To estimate proportion of off-label medication use in neonates and to evaluate evidence of efficacy and safety of these medications.

Methods: Chart audit in neonatal intensive care units of two institutions in Chandigarh, India.

Results: Among 568 prescriptions in 156 neonates, 286 (50%) were off-label. Of these, 56% drugs were not approved for use in neonatal age group and 26% prescriptions were off-label for frequency, dose, indication, route or rate. Most common off-label drugs were anti-infective and antiepileptic. Despite lack of regulatory approval, one-third off-label drugs had level I-II evidence of safety and efficacy for use in neonates.

Conclusion: Use of off-label drugs is common in sick neonates.