Circumstances Under Which Children Should Be Prescribed Drugs for Off-Label Use

Circumstances Under Which Children Should Be Prescribed Drugs for Off-Label Use

Prescription of off-label medication in pediatrics is common due to the lack of specific data regarding efficacy, dosing, and safety of medications prescribed to children. One circumstance that children are prescribed off-label drugs is when there is no specific governmental approval or drug information for on-label pediatric prescribing (Allen et al., 2018). This leads to the clinician prescribing the medicine off-label. For example, enalapril has an FDA-approved indication for treating heart failure and hypertension in adults but has an FDA-approved indication for hypertension only in children. It is, however, commonly used by clinicians to treat heart failure in children. Other circumstances include lack of standard treatment, lack of clinical trials, and shortage of alternative therapy for the children. Examples include the use of antidepressants to treat attention deficit hyperactive disorder.