FDA Investigating Safety of Codeine Cough-and-Cold Medicines in Kids

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

The FDA warned on Wednesday that cough-and-cold medications with codeine could pose a risk for serious adverse reactions, including difficult or slowed breathing, in children younger than 18 years of age.

The agency will continue to review this issue and will consider following recent European Medicines Agency recommendations not to use codeine in children younger than 12 years or in 12- to 18-year-olds with chronic breathing conditions (e.g., asthma).

For now, the agency recommends that healthcare providers use caution in prescribing or recommending these products.

The agency added a boxed warning to codeine-containing products in 2013 that cautions against using them in children undergoing adenoidectomy or tonsillectomy.