Postoperative deaths have occurred in children with sleep apnea who received codeine for pain relief, according to the FDA report. The risk of death is increased in children with ultra-rapid metabolizers of codeine, a genetic ability that causes codeine to be converted into fatal amounts of morphine in the liver.
A Boxed Warning, the agency’s strongest advisory, will be added to all drug labels of codeine-containing products to inform users of the risks associated with pain management use for children having tonsillectomy and adenoidectomy procedures.
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