The Food and Drug Administration should not reverse recent pediatric-focused label changes for OxyContin, an approved opioid drug (“FDA must revisit OxyContin decision’’).

The Globe argued that there was no harm to expunging these changes because pediatric physicians are already using OxyContin “off-label’’ and “carefully calculating dosages.’’ This only highlights the unfortunate truth that physicians who treat pediatric patients are often forced to prescribe medications approved for use in adults by extrapolation of efficacy, safety, and dose.

But over the years we have made errors. We have treated children with medications that have not been effective or that have caused unanticipated mortality and morbidity. Our best extrapolations of dose have sometimes proved to be subtherapeutic or toxic.

Congress addressed issues related to inequity in pediatric pharmacotherapeutics when it made permanent the intelligent reforms of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. These laws empowered the FDA to require that manufacturers conduct studies in pediatric patients. By the close of 2015, new pediatric labeling information had been added for 608 drugs, with 556 labels including information from new pediatric studies.

Concerns that abuse may escalate due to inappropriate pharmaceutical promotion should be addressed by upgrading the FDA’s capability, through new regulations and better funding, to ensure that advertisements are responsible and accurate, not by removing label information that guides safe pediatric treatment.

Dr. Mark Hudak

Jacksonville, Fla.

The writer is professor and chairman of pediatrics at the University of Florida College of Medicine-Jacksonville and chairman of the FDA Pediatric Advisory Committee.