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July 15, 2015
Safety of Codeine Medications for Children Under FDA Scrutiny
Washington, D.C.—The safety of codeine medications to treat cough and colds in children under 18 is being investigated by the FDA because of the potential for serious side effects, including slowed or difficult breathing. In a 2013 safety alert, the FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids. This spring, the European Medicines Agency (EMA) came out against the use of codeine to treat cough and cold in children under age 12 years, adding that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma. The FDA said it will continue to evaluate this safety issue in light of the EMA recommendations, adding its own conclusions when a review is complete. Meanwhile, public health officials advise parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child to stop administering the codeine product and seek emergency medical attention immediately. Parents and caregivers are urged to read labels to determine if a medication contains codeine and to bring any questions to their pharmacist or other healthcare provider. Healthcare professionals, including pharmacists, are advised to follow the recommendations on the drug labels and use caution when recommending or prescribing codeine-containing cough-and-cold medicines to children. In another announcement concerning pediatric medications, the FDA announced its plan to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription otic products labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops, which contain active ingredients such as benzocaine and hydrocortisone, have not been evaluated for safety, effectiveness, and quality, according to the FDA. In fact, pharmacists and other healthcare professionals may not be aware of this because the products’ labels fail to disclose their lack of FDA approval, according to a recent safety announcement. In a Federal Register notice, the FDA warned the companies to stop manufacturing the unapproved prescription otic products or potentially face criminal charges. “Taking enforcement actions against these unapproved products will protect patients from unnecessary risks,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products.”
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