Children are still prescribed codeine despite FDA warnings, study finds
pharmafile | November 20, 2017 | News story | Medical Communications, Research and Development, Sales and Marketing | US, codeine, opioid crisis, opioids, pharma
A new study from the American Academy of Pediatrics has found that, despite warnings from the FDA, doctors are still prescribing codeine, an opioid painkiller, for children after undergoing surgery.
The US regulator originally issued an official warning against the prescription of codeine for children, specifically following tonsillectomy and adenoidectomy, back in 2013 along with an order which required any such medication to carry black box warnings.
These moves were made after the medication was found to cause serious breathing problems which led to the deaths of 24 children between 1969 and 2015, and succeeded in bringing down codeine prescriptions by around 13% overall.
“A decreasing number of children were receiving codeine even before the FDA investigation, but once that investigation was over, there was a huge drop,” explained Dr Kao-Ping Chua, lead author of the new study and Assistant Professor of Pediatrics and Communicable Diseases at the University of Michigan and C.S. Mott Children’s Hospital. “That’s kind of what we expect. An FDA black box warning should actually decrease inappropriate codeine prescribing.”
The study collected data on more the 350,000 privately insured children under the age of 18 who had undergone either a tonsillectomy or an adenoidectomy. It found that around 5%, or one in 20 children, are still being given the drug as a solution for pain since December 2015.
“5% may not sound like a huge number, but you have to remember that the tonsillectomy and adenoid removal is the second most common surgery in children,” Chua said.
While Codeine itself has no effect on pain, it is dangerous because it is converted by a liver enzyme into morphine, and the speed of this conversion can vary greatly from patient to patient.
“Approximately 1-2% of people are ‘ultra-metabolizers’ who convert codeine to morphine extremely quickly, causing a rapid spike in blood morphine levels and a resulting risk of overdose,” Chua explained. “Of course, no one can tell who is and who is not an ultra-metabolizer without doing expensive testing that may not come back fast enough to inform decisions about how to manage pain.”
“This is an unacceptable gamble given that there are better alternatives,” he added. “Tylenol or ibuprofen are both over-the-counter agents that have been shown to be very effective in treating post-surgical pain, and they don’t have the same sort of safety concerns as codeine.”
Matt Fellows
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