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.
Read Drug Safety Communication
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