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

A recent study 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.

The warning was pertaining to the opioid’s significant safety risks.

The study, “Effect of FDA Investigation on Opioid Prescribing to Children after Tonsillectomy/Adenoidectomy” 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 these surgeries decreased by 13.3 percentage points, a significant decline. Yet 5.1 percent of children still received codeine prescriptions, nearly three years after the 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.

Michaela Madison Reporting

Leave a Reply