Safety of Codeine Products for Cough, Cold in Children Under Investigation

Safety of Codeine Products for Cough, Cold in Children Under Investigation
Safety of Codeine Products for Cough, Cold in Children Under Investigation

The Food and Drug Administration (FDA) is evaluating the safety of using codeine-containing products to treat cough and cold in children <18 years due to the potential for serious adverse reactions such as slow or difficult breathing.

In 2013, the FDA warned against the use of codeine in children who recently had surgery to remove their tonsils and/or adenoids. Then in 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children <12 years, and that codeine is not recommended in adolescents between 12–18 years who have breathing problems, including those with asthma and other chronic breathing problems.

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Codeine is an opioid that is indicated to treat mild to moderate pain and to reduce cough. Codeine is found in combination with other prescription and over-the-counter (OTC) cough medications. The FDA recommends that parents and caregivers should stop giving codeine to their child and seek medical attention if any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness develop.

The FDA will consider the EMA recommendations and continue their investigation on this safety issue. Upon completion of the review, the final conclusions and recommendations will be presented.

For more information call (855) 543-3784 or visit FDA.gov.

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