FDA Reviewing Safety of Codeine Cough Syrup for KidsJuly 2, 2015 — The FDA is evaluating the safety of cough syrups for children that contain codeine due to the risk of serious side effects, including slowed breathing and death.

The announcement came after the European Medicines Agency (EMA) warned that children under 12 years old should not use codeine for cough and cold due to the risk of serious side effects, including breathing problems that can be fatal.

Codeine is converted into morphine in the body, but 1-7% of people convert it at a faster rate than normal, which spikes levels of morphine in their blood. The EMA also warned that breastfeeding women and “ulra-rapid metabolizers” should not use codeine.

The FDA is evaluating the safety of codeine in children and will consider the EMA recommendations. In the meantime, the agency warned:

“Parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should seek medical attention immediately, as these are signs of overdose.”

The FDA previously warned that over-the-counter cough and cold products should not be used in children under two years old. The agency has also advised against giving codeine to children after a tonsillectomy and/or adenoidectomy after three reports of death and one report of breathing problems.

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