July 2, 2015 — After European health officials warned that codeine cough syrups should not be used in children under 12 years old, the FDA has announced that it will open a safety investigation.
Codeine is converted into morphine in the body. The problem is that 1-7% of the general population (and up to 28% of certain ethnic groups) are “ultra-rapid metabolizers.” For these individuals, codeine is converted to morphine much faster than normal. High levels of morphine in the body can cause breathing difficulty, which may be fatal, especially for children.
Due to these risks, the European Medicines Agency (EMA) has warned that cough syrups containing codeine should not be used by children, breastfeeding women, and anyone who is an “ultra-rapid metabolizer.”
The FDA has not asked manufacturers to update labels, but recommends:
“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 is aware of the serious risks codeine poses to children. The agency has already issued warnings about children who were seriously injured or died after being given codeine after a tonsillectomy and/or adenoidectomy. The FDA has also warned against giving over-the-counter cough and cold products to children under two years old.
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