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FDA to evaluate risks for children using codeine medications

The FDA announced that it is examining the risks associated with children under the age of 18 taking codeine-containing medications for the treatment of coughs and colds due to potentially serious adverse events, according to a safety announcement.

The decision to evaluate safety concerns of codeine in children comes after the European Medicines Agency made the announcement that codeine was not to be used for cough and cold treatment in children under 12. Additionally, they recommended that adolescents with breathing problems between the ages of 12 and 18 years not take codeine-containing medications.

In children taking codeine medications, parents and health care providers should be aware of breathing difficulties, including shallow breathing, difficult or noisy breathing, as well as any signs of confusion or unusual sleepiness. Children with pre-existing breathing problems, such as asthma, may be more susceptible to harmful side effects. If any of these adverse events are present, the child should discontinue the use codeine and medical attention should be sought immediately, according to the safety announcement.

The FDA has previously warned against using codeine medications in children who had recently undergone surgery for the removal of their tonsils or adenoids.

Caution should be used when prescribing children codeine-containing medications for cough and cold, the FDA warned.

“We are evaluating all available information and will also consult with external experts by convening an advisory committee to discuss these safety issues. We will communicate our final conclusions when our review is complete,” the FDA stated in the release.