FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Opioids Not for Coughs in Kids, FDA Advisory Committee Says

Sept. 14, 2017
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The FDA’s Pediatric Advisory Committee voted overwhelmingly that the risks outweigh the benefits of using opioids to treat coughs in children.

The committee’s decision amounts to a recommendation to FDA officials that cough suppression be removed from the list of approved indications for codeine and hydrocodone medications in patients under the age of 18.

The FDA in April mandated changes to the labeling of codeine medications to warn that they should not be used to treat cough in children under 12. In its meeting, the committee voted 24-0 against the use of those medicines for patients under 18 affected by coughs due to colds or allergies.

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