Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication

FDA
Posted

The Federal Drug Administration (FDA) is investigating the potential risks of using medicines with codeine to treat coughs and colds in children because of the potential for serious side effects, including slowed or difficult breathing.

Codeine is a type of opioid used to treat mild to moderate pain and reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines.

The European Medicines Agency (EMA) announced in April that codeine must not be used to treat cough and cold in children younger than 12. It also said codeine isn’t recommended for children and teens between ages 12 and 18 who have breathing problems, such as asthma. FDA will continue to evaluate this safety issue and will consider the EMA recommendations.

Risk: Children, especially those who already have breathing problems, may be more susceptible to serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.

Recommendations:

Read the product label to find out whether a medicine contains codeine. Talk with your child’s health care professional or a pharmacist if you have questions or concerns.

If your child shows signs of slow, shallow breathing, difficult or noisy breathing, confusion or unusual sleepiness, stop giving codeine. Get immediate medical attention – go to the emergency room or call 911.

Report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online: www.fda.gov/MedWatch/report

Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178