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F.D.A. Strengthens Warnings for Painkillers in Children

The Food and Drug Administration announced on Thursday that any child younger than 12 should not take the opioid codeine and that those 18 and younger should not take tramadol, another painkiller, after certain types of surgery. In addition, nursing mothers should avoid both opioids because they pose dangers to breast-feeding babies, the agency said.

Drug manufacturers will be required to update their package inserts to reflect the new contraindications, the strongest kind of warning, to alert doctors and parents that children can have trouble breathing or die after taking these drugs. Some over-the-counter cough or cold remedies contain codeine, so parents should read all labels to avoid accidentally giving it to their child.

Teenagers with certain conditions like severe lung disease, obesity or obstructive sleep apnea that can impair breathing may be at particular risk, the agency cautioned.


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