FDA: Codeine Now Contraindicated for Pain and Cough in Kids

By Amy Orciari Herman

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

The FDA has issued new warnings against using prescription codeine and tramadol in children and adolescents.

Reviewing adverse event reports from nearly 50 years, the agency found 64 reports of severe breathing problems, including 24 deaths, linked to codeine in children and adolescents. An additional nine cases, including three deaths, were linked to tramadol. A literature review noted excessive sleepiness and breathing problems, including one death, in breast-fed infants whose mothers used codeine.

Here are the new contraindications and warnings:

• Contraindication: Codeine should not be used for pain or cough and tramadol shouldn't be used for pain in children under 12 years.

• Contraindication: Tramadol shouldn't be used in children under 18 years to treat pain after tonsillectomy or adenoidectomy.

• Warning: It's recommended that codeine and tramadol not be used in adolescents aged 12–18 who are obese or have conditions associated with breathing problems, such as obstructive sleep apnea or severe lung disease.

• Strengthened warning: Breast-feeding is not recommended during codeine or tramadol use.