FDA panel says risk of opioid use in kids’ cough medicines outweighs benefits
ROCKVILLE, Md. — A federal advisory committee sent a strong message to the Food and Drug Administration on Monday, declaring nearly unanimously that the risks of using certain opioids in children’s cough medications outweighs the benefits.
“We have a disease with a very low risk profile, yet we’re looking at a drug that has a risk of death,” said Dr. Christy Turer, an assistant professor of pediatrics, clinical sciences, and medicine at the University of Texas Southwestern. “That, to me, seems very disproportionate.”
The recommendation by the FDA advisory committee was part of the agency’s ongoing effort to consider whether and how opiates and opioids should be used in medicine for children, an issue that has been the subject of hearings and warnings for a decade. The panel on Monday was convened to consider whether the benefits of children using cough medications containing codeine or hydrocodone outweigh the risks, focusing specifically on children in two age groups: those 6 to 12, for whom the FDA already recommends against using codeine for cough, and those 12 to 18.