FROM PEDIATRICS

A Food and Drug Administration black box warning led to a reduction but not an elimination of codeine pain relief after tonsillectomy and/or adenoidectomy – and there has been inappropriate substitution of other opioids rather than nonopioid pain relievers such as ibuprofen, said Kao-Ping Chua, MD, PhD , of the University of Chicago, and his associates.

Codeine has been one of the most commonly prescribed analgesics for children after tonsillectomies and adenoidectomies because it was considered safe.

But between 1969 and 2012, the FDA received eight reports of children who died or overdosed while taking codeine after having undergone these surgeries. In many cases, these deaths were associated “with genetic polymorphisms resulting in high function of the enzyme that metabolizes codeine to morphine, leading to dangerously elevated blood morphine levels,” the investigators wrote.

The FDA issued a boxed warning Feb. 20, 2013, recommending against codeine use in all children undergoing tonsillectomy and/or adenoidectomy. Also, children with obstructive sleep apnea are at risk of opioid-related respiratory depression.

A retrospective study of 362,992 children aged 0-18 years who underwent tonsillectomy and/or adenoidectomy was undertaken in 2010-2015, prior to and after the FDA issued the boxed warning against codeine use. In January 2010, codeine products were prescribed in 47% of cases, compared with 48% for hydrocodone, 4% for oxycodone, and less than 1% for other opioid products. In December 2015, codeine was prescribed in 9% of cases, compared with 73% for hydrocodone, 17% for oxycodone, and less than 1% for other opioid products.

“The unadjusted proportion of children receiving alternative opioids rose substantially during the study period, presumably because of factors other than the investigation itself,” said Dr. Chua and his associates. “This increase deserves further examination, given the abuse liability associated with higher-potency opioids,‍ as well as the growing evidence of genetic variability in the metabolism of many alternative opioids, including oxycodone and tramadol.

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

Read more in Pediatrics (2017 Nov 16. doi: 10.1542/ peds.2017-1765).

pdnews@frontlinemedcom.com

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