FDA to Evaluate Pediatric Cough Medicines Containing Opioids

On August 21, 2017, FDA Commissioner Scott Gottlieb announced that FDA will be evaluating the “complex issue” of the use by children of prescription opioid products containing hydrocodone or codeine. A meeting of the Pediatric Advisory Committee will look at the benefits and risks of the pediatric use of cough medicines containing opioids. The agency will also use information gained during a roundtable of professional groups held in April 2017.

“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,” Gottlieb said in a statement.

In April 2017, the agency announced changes to the labeling of opioid medications to protect children from the risks associated with these medications. The changes included adding alerts that codeine should not be used in children under 12 years of age.