Parents Warned about Danger of Codeine Cough-and-Cold Medicines for Children

The Food and Drug Administration (FDA) has issued a Drug Safety Communication warning parents about the danger of giving medicines containing codeine to treat coughs and colds in children. These medicines can cause serious side effects, including slowed or difficult breathing.

The FDA explains that codeine, an opioid, is used to treat mild to moderate pain and reduce coughing. According to the FDA, codeine is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines. In April, the European Medicines Agency (EMA) announced that codeine should not be used to treat coughs and colds in children younger than 12. In addition, the EMA said codeine is not recommended for children and teens from 12 to18 who have asthma or other breathing problems. The FDA will continue to evaluate the safety issues involving codeine and will consider the EMA recommendations.Children, and especially children who have breathing problems, may be more susceptible to serious side effects from codeine. In 2013, the FDA warned against giving codeine medications to children after surgery to remove their tonsils and/or adenoids. The agency added a boxed warning—its strongest label warning—to the drug labels of codeine-containing products about the risk of codeine in post-operative pain management in children who have had a tonsillectomy and/or adenoidectomy. A contraindication, which is the FDA’s formal means for making a strong recommendation against use of a drug in certain patients, was added to restrict codeine from being used after tonsillectomy.

The FDA advises parents and caregivers to monitor a child taking a codeine medicine for signs of breathing difficulties. These include slow, shallow breathing, difficult or noisy breathing, confusion or unusual sleepiness. In the event of such signs, the parent or caregiver should stop giving codeine and seek immediate medical attention by taking the child to an emergency room or calling 911.

Parents and caregivers should read the product label of any cough-and-cold medicine they plan to give a child to find out if the product contains codeine. The FDA recommends that parents and caregivers speak to a health care professional or a pharmacist with any medication questions and concerns.

The FDA encourages parents and health care professionals to report adverse events or side effects related to the use of codeine medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report. Reports can be made online, by mail, or by fax to 1-800-FDA-0178.

 

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