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FDA Risk Warning Slowed But Did Not Stop the Prescribing of Codeine to Some Children After Tonsillectomy

11/16/2017

​A study published in the December 2017 issue of Pediatrics finds that 1 in 20 children were prescribed codeine after having a tonsillectomy and/or adenoidectomy at the end of 2015, despite a warning by the Food and Drug Administration regarding the opioid's significant safety risks. The study, "Effect of FDA Investigation on Opioid Prescribing to Children after Tonsillectomy/Adenoidectomy" (published online Nov. 16), analyzed the records of 362,992 privately insured children in the 2010-2015 Truven MarketScan Commercial Claims and Encounters database who underwent a tonsillectomy and/or adenoidectomy. The FDA, following an investigation, in February 2013 issued a black box warning about safety and efficacy issues associated with prescribing codeine to children after the surgeries. Researchers found that, after the FDA warning, codeine prescribing after a tonsillectomy and/or adenoidectomy decreased by 13.3 percentage points, a significant decline. Yet 5.1 percent of children still were prescribed codeine following a tonsillectomy and/or adenoidectomy in December 2015, nearly three years after the black box warning. The authors conclude that there is still a need to eliminate inappropriate codeine prescribing and encourage the use of effective non-opioid medications such as ibuprofen following these surgeries.

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