Off-label Drug Use in Pediatrics
The practice of physicians prescribing off-label medications in children is universal due
to a lack of pediatric-specific data regarding the dosing, efficacy, and safety of drugs regularly
prescribed to children. Off-label use is the use of pharmaceutical medications outside the product
license for an unapproved indication, an unapproved age group, unapproved dosage, or
unapproved form of administration. Off-label use of drugs among neonates and children is
widespread. Therefore, this paper aims to explain the circumstances under which children should
be prescribed drugs for off-label use and which strategies can be taken to make the off-label use
and dosage of drugs safer for children from infancy to adolescence.
Circumstances where Children are prescribed drugs Off-Label Use
‘‘Off label use’ is the use of a drug which has a marketing authorization, but is used for a‐
condition, at a dose, via a route or for an age that is not listed in its product characteristics
(Maria 2014). It involves using drugs out of the preapproved specifications and licenses and not
necessarily improper use of medications for that age group. With limited research and clinical
evidence available on the effects and dosages of some essential drugs on children, the benefits
provided from the use of these drugs may validate their use out of the preapproved
specifications.
Some examples of psychopharmacological drugs used off-label are clonidine and
haloperidol for schizophrenia; valproate and lithium as mood stabilizers; fluoxetine and
clomipramine as antidepressants; and diazepam for seizure management. Other drugs include
antimicrobials such as gentamycin and ceftriaxone; morphine used for pain management; and
atenolol for blood pressure management (Maria, 2014
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