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FDA Warns Against Giving Children Codeine After Tonsillectomy

Warning comes in response to 3 pediatric deaths and 1 life-threatening case of respiratory depression.

Published: February 21, 2013

The FDA is warning healthcare providers to avoid prescribing codeine-containing drugs to children, particularly in those who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. If you do prescribe codeine to children, the FDA is urging you to use the lowest effective dose for the shortest period of time and to give the drug on an as-needed basis as opposed to scheduling it around the clock.

This warning follows reports of children (aged 2 to 5 years) who developed serious adverse effects or died after they were administered codeine for pain relief post tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. Recently, 3 pediatric deaths and 1 non-fatal but life-threatening case of respiratory depression were documented in the medical literature.

"These children had evidence of being ultra-rapid metabolizers of codeine, which is an inherited ability that causes the liver to convert codeine into life-threatening or fatal amounts of morphine in the body," the agency says. Each of the children had received doses of codeine that were within the typical dose range.

The new boxed warning, the strongest available, will be added to the label of codeine-containing products. The labels will also include a recommendation that the drugs not be used among pediatric patients undergoing these particular procedures.

The FDA is currently conducting a safety review of codeine to determine if there are additional cases of inadvertent overdose or death among children, and if these adverse events occur during treatment of post-operative pain following other types of surgery or procedures.

Dan O'Connor

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