FDA Panel Recommends Tighter Regulation for Codeine

A joint FDA panel has recommended new restrictions for use of codeine in children. The panel also advised it be prohibited from all over-the-counter (OTC) drug formulations regardless of age.

Members of the FDA’s Pulmonary-Allergy Drugs and Drug Safety and Risk Management advisory committees held a public hearing on the new contraindication recommendations. The panel voted unanimously (28-0) in favor of prohibiting codeine from the OTC monograph, with one abstention.

The use of codeine for pain relief in children was also considered, as the panel voted 28-1 in favor of expanding the opioid’s contraindication for use in pain management among pediatric populations. Three-quarters of the panel advocated a contraindication for anyone under the age of 18 years.

Codeine also received a recommended contraindication for treating cough, after the panel voted 26-3 in favor of the restriction. Nearly three-quarters of the panel, meanwhile, advocated the strongest contraindication option available, which excludes those under the age of 18 years.

The American Academy of Pediatricians (AAP) supported the contraindications for cough and pain management in children, in addition to removing codeine from the OTC monograph for cough treatment. The concern in the pediatric population when codeine is used for pain relief is the drug’s related risk of life-threatening respiratory failure, which prompted a boxed warning on the label of codeine-related products in 2012.

"Because of its variability in metabolism, the increased risk of adverse effects in children and the lack of data showing efficacy for treating cough in children, the use of codeine or any other opioid cannot be recommended for the treatment of cough in children,” said Constance "Connie" Houck, chair of the AAP’s surgical advisory panel, in her testimony during the hearing’s public comments period.

“Likewise,” Houck added, “for acute and postoperative pain in children, alternative strategies should be recommended, including other opioids.”

—Drew Amorosi