Off-Label Drug Use in Pediatrics
In the United States, the FDA approves a drug for a certain set of uses after the drug has been put through rigorous studies. Once approved, the FDA and the drug manufacturer create the drug’s “label†which is an information document that details the drug’s specific approved uses. However, researchers may later discover that the drug can be used to treat other conditions. In this case, doctors may legally prescribe a drug to treat a condition not listed on the drug’s label. Thus, “off-label drug use†means to use a drug for a purpose not listed on the drug’s label. Typically, an ethical doctor will only prescribe a drug for off-label purposes when the benefits of use outweigh the risks. Credible medical evidence such as clinical trials and medical literature should also support the doctor’s decision.
Examples of off-label drugs
Drug (Brand name) Common on-label use Common off-label use
bupropion (Wellbutrin) depression bipolar
diphenhydramine (Benadryl) allergy sx, insomnia N/V related to pregnancy
escitalopram (Lexapro) depression, anxiety bipolar
fluoxetine (Prozac) depression, OCD, bipolar autism spectrum disorders
montelukast (Singulair) asthma COPD
quetiapine (Seroquel) schizophrenia, bipolar insomnia
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
To Prepare
- Review the interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
- Reflect on situations in which children should be prescribed drugs for off-label use.
- Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.
Write a 2-page narrative in APA format that addresses the following:
- Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
- Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.