In 2013, the agency recommended these products not be used for children following tonsillectomy and/or surgery on adenoids due to slow or difficult breathing associated with its use. But the European Medicines Agency issued a much stronger statement in April, saying cough syrup with codeine is now contraindicated for all children under 12, as well as for those 12 to 18 with asthma or chronic breathing problems.
“FDA will continue to evaluate this safety issue and will consider the EMA recommendations. We will convene a public advisory committee meeting to discuss these issues and provide input regarding whether additional action by FDA is needed,” the agency said Wednesday.
During the FDA review, the agency encouraged healthcare professionals to continue following the recommendations on drug labels, but urged caution when prescribing children cough-and-cold products that contain codeine. They urged that both healthcare professionals and patients report all adverse events observed through use of these products to the FDA’s MedWatch Safety and Adverse Event Reporting Program.
The agency also asked that parents and caregivers speak with healthcare professionals or a pharmacist if they have questions or concerns about products containing codeine.