FDA evaluating the potential risks of using codeine cough-and-cold medicines in children
The U.S. Food and Drug Administration (FDA) is investigating the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. We are evaluating all available information and will also consult with external experts by convening an advisory committee to discuss these safety issues. We will communicate our final conclusions when our review is complete.
Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911.