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FDA to Evaluate Safety Codeine Cough-and-Cold Medicines in Children

Filed August 27th, 2015 Lillian Chiu

The U.S. Food and Drug Administration (FDA) will be evaluating the risks of using cough-and-cold medicines containing codeine in children due to “the potential for serious side effects, including slowed or difficult breathing” according to Drug Safety Communication posted on their website. Parents and caregivers should read the label to determine if a medicine has codeine, and speak with their child’s physician if they have concerns. The FDA says to stop giving codeine if they have slow, shallow breathing, difficult or noisy breathing, confusion or unusual sleepiness.

Codeine is found in many over-the-counter (OTC) cough-and-cold medicines. It is a type of opioid used to treat mild to moderate pain and mitigate coughing.

In April, the European Medicines Agency said in April that children younger than 12 should not be treated with codeine. Patients between the ages 12 and 18 who have breathing issues such as asthma should also not use codeine. The FDA said it “will continue to evaluate this safety issue and will consider the EMA recommendations.” In 2013, the FDA said codeine should not be used in children who recently had surgery to remove their tonsil and/or adenoids.

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