“Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration” (Stafford, 2008). Off-label ways to use drugs are prescription drugs and over-the counter drugs (OTCs)…
The use of off-label drugs is most common among oncology and pediatric patients due to the lack of appropriate medicines and therapies. In certain circumstances, the use of off-label medicines proved beneficial for children, especially when all the approved medicines fail to bring the desired results as in the case of cancer. American Cancer Society reveals that some of the chemotherapy medicines are approved for one type of cancer but it has the potential to cure the other types of tumors.
Other example of beneficial use of off-label medicine is Beta-blockers. FDA approved it for the patients of high blood pressure but it proved in curing heart diseases also. But before prescribing the off-label drugs, it is the duty of medical practitioners to inform the parents or guardians of children about this very fact; and reveal the side effects that may occur. They should also inform the alternative remedies available with them. Besides, medical practitioners should inform the company or relevant medical authority about the adverse effects, if they occur. In the case of United States vs. Evers, the court even authorizes a medical practitioner to use off-label drugs if they were not contraindicated (Fauber, 2012).
Some off-label drugs require extra care and attention when use in Pediatrics. Example includes diazepam rectal solution in children under 1 year (not licensed for age group), amiloride tablets in any children (formulation), or rectal injection of lorazepam for a child with an acute seizure (route). An example of unlicensed use is the preparation of a suspension from a tablet by the hospital ...
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