Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

An advisory committee to the FDA has recommended that codeine be contraindicated for pain and cough management in children and adolescents over concerns of respiratory depression and death. In addition, they recommended restricting codeine’s over-the-counter availability for this group.

Of 29 voting members, 20 voted to contraindicate use of the drug for pain and cough in children younger than 18 years old. Most of the others voted to restrict its use only in younger children.

Currently, codeine products have a boxed warning that recommends against their use in children undergoing adenoidectomy or tonsillectomy. In Europe, codeine is contraindicated in children under age 12 for cold and cough, and the European Medicines Agency recommends against using the drug in those aged 12 to 18 years old who have breathing difficulties.

The FDA is not required to follow the recommendations of its advisory committees, but it usually does.


FDA briefing document (Free PDF) Full briefing materials (Free)

Background: Physician’s First Watch coverage of FDA codeine safety in children (Free)