Drugs are used off-label when they’re not intended to be. Off-label usage is very common in pediatrics due to the lack of guidelines for dosage and the number of medications that are specifically tested and researched with children. In cases where there aren’t any approved drugs to treat the child’s condition, or when a medication has been proven effective for adults and considered safe for children use, off-label prescriptions should be given.
Healthcare providers should be informed about the potential risks of prescribing drugs off-label and ensure the benefits and risks of each drug are thoroughly evaluated. To ensure that medication is used safely, a multidisciplinary approach involving parents, healthcare providers, and the patient can be helpful. Prescriptions of medications should be based on the pharmacokinetic differences between adults and children.
When used by pediatricians, certain off-label medicines require additional care. Antidepressants such as fluoxetine or sertraline, for example, have been linked to an increased risk in suicidal thoughts among pediatric patients. Patients taking these medications should be closely monitored by their providers, particularly during the initial months of treatment. The risk of birth defects is increased when antiepileptics like carbamazepine or valproate are prescribed to women who are pregnant.
Summary: Off-label drug use in children is common because of the lack of research and guidelines for dosage. In order to make the off-label drug use for children safer, health care providers need to carefully evaluate risks and benefits, take into account age-related differences in pharmacokinetics between children and adults and include patients, caregivers, and parents in the process of drug therapy. Certain off-label medications, such as antidepressants or antiepileptics, require special attention and care when administered to children.