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Study: Despite FDA warning, codeine still prescribed to some children :

November 16, 2017

Roughly 5% of children were prescribed codeine after a tonsillectomy or adenoidectomy despite federal safety warnings, according to a new study.

Researchers called the practice an “unnecessary gamble” that can lead to respiratory depression for some and may not relieve their pain.

Some children metabolize codeine quickly, leading to elevated morphine levels. From 1969-2012, 13 children died or overdosed after taking codeine, including eight who had undergone a tonsillectomy or adenoidectomy. The cases prompted the Food and Drug Administration (FDA) to issue a boxed warning in February 2013.

Researcher set out to determine the warning’s impact and detailed their findings in the study “Effect of FDA Investigation on Opioid Prescribing to Children After Tonsillectomy/Adenoidectomy” (Chua KP, et al. Pediatrics. Nov. 16, 2017,

They analyzed data from the 2010-2015 MarketScan Commercial Claims and Encounters database on 362,992 privately insured children who underwent a tonsillectomy or adenoidectomy. In January 2010, 31% of these children had received a prescription for codeine shortly after the surgery. In December 2015, more than two years after the FDA warning, that figure dropped to 5.1%. Authors said the FDA’s safety investigation was associated with a 13.3 percentage point drop in codeine prescriptions.

During the study period, the percent of children who were prescribed an alternative opioid rose from 31.7% to 46.1%, but there was not a significant link between the FDA investigation and this change, authors wrote.

In December 2015, 72.7% of opioids prescribed to children after a tonsillectomy or adenoidectomy were hydrocodone products, 17.4% were oxycodone, 9.1% were codeine and 0.8% were other opioids. Authors noted the high potency of these drugs and called for additional study on prescribing practices.

They also said quality improvement efforts are needed to reach physicians who may be resistant to change, disagree that codeine has risks or lack experience with other drugs.

“Future quality improvement efforts should focus on eliminating this residual inappropriate codeine prescribing and on encouraging the use of effective non-opioid medications such as ibuprofen,” authors wrote.

In 2016, the Academy released a clinical report Codeine: Time to Say ‘No,’ which details the risks of using codeine and urges additional restrictions on its use.

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