FDA Investigating Risks of Codeine Cough-and-Cold Medicines for Children

The Food and Drug Administration (FDA) is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years of age.

The FDA warns of the potential for serious side effects, including slowed or difficult breathing, especially in children who already have breathing problems. In 2013, the FDA warned against the use of codeine for children who had recently had their tonsils or adenoids removed and the agency ordered a boxed warning to be added to the labels of codeine-containing products to warn about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy.Codeine is an opioid, a narcotic medicine used to treat mild to moderate pain and also to reduce coughing.  Codeine is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines. Codeine works by changing the way the brain responds to pain and by decreasing the activity in the part of the brain that causes coughing. The body converts codeine to the opioid morphine. Some people convert codeine to morphine faster and more completely than usual, resulting in higher amounts of morphine in their blood, the FDA explains. High levels of morphine can result in problems, including breathing difficulty that may lead to death.

The European Medicines Agency (EMA) announced in April that codeine must not be used to treat coughs and colds in children under 12, and that codeine is not recommended for those between 12 and 18 who have breathing problems, including children and adolescents with asthma and other chronic breathing problems.

The FDA advises parents and caregivers to carefully monitor a child taking codeine for any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness. If the child shows any of these signs, codeine should be stopped and the parents should seek immediate medical attention by taking the child to the emergency room or by calling 911. Parents and caregivers should always read the product label to see if a medicine contains codeine and they should talk with a health care professional or a pharmacist if they have any questions or concerns. The FDA advises health care professionals to exercise caution when prescribing or recommending codeine-containing cough-and-cold medicines for children.

In the July 1 safety alert, the FDA said it will continue to evaluate this safety issue and will convene a public advisory committee meeting to discuss these issues and gather input about whether additional FDA action is needed. Notice of the meeting will be posted in the Federal Register and on the Advisory Committees web page. The FDA will consider the European Medicines Agency’s recommendations in its deliberations. Final conclusions and recommendations will be announced when the FDA review is complete.

 

 

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