FDA evaluating prescription opioid medications approved to treat cough in children

US Food and Drug Administration Commissioner Scott Gottlieb says there’s perhaps no more important mandate that the FDA has than safeguarding the health and safety of children. “For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health, stated FDA,” he states.

With this in mind, the FDA yesterday  announced an upcoming meeting of the Pediatric Advisory Committee that will focus on the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients, including current treatment practices and benefit-risk considerations. The panel of independent experts will provide valuable input to help inform the agency’s decision-making processes related to these medications.

It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions. This is an area that the agency is continuing to evaluate. As part of these efforts, the FDA announced required changes in April 2017 to the labeling of prescription codeine products in order to help better protect children from serious risks associated with these opioid medications, including life-threatening respiratory depression and death. Those changes include adding a contraindication to drug labels alerting that codeine should not be used for any reason, including treatment of cough, in children younger than 12 years.