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Office-Based Physicians Commonly Order Drugs Off-Label For Children


Office-based physicians are increasingly ordering drugs for children off-label, a practice that is legal and often based on extensive clinical experience and evidence of safe, effective use of the drug. A study in the October 2019 issue of Pediatrics, “Trends in Off-Label Drug Use in Ambulatory Setting: 2006-2015,” published online Sept. 16, looked at how often and why office-based physicians prescribed off-label use of drugs for children in non-hospital settings in the United States. They found that prescribing drugs off-label – outside of the Food and Drug Administration-approved age, weight or reason for prescribing – has increased over the past 10 years, especially for unapproved conditions. In neonates under 30 days old, drugs to treat gastrointestinal conditions are the most commonly prescribed off-label drugs, while antidepressants are the most commonly prescribed off-label drugs in adolescents ages 12-17. The authors note that despite legislation aimed at increasing clinical drug trials of medications for children, there is still a lack of data about many commonly used drugs. The authors hope that studies such as this one can help inform ongoing education, research and policies around safe and effective use of medications in children.

Editor's note: A solicited commentary, "Off-Label Prescribing in Children Remains High: A Call for Prioritized Research," also will  be published in Pediatrics.


The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit and follow us on Twitter @AmerAcadPeds