FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids

The Food & Drug Administration announced on Thursday that they will be strengthening the requirements for drug labels for codeine and tramadol to protect children.

"Our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe", Dr. Throckmorton said.

The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.

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The FDA hasn't approved tramadol for use in children.

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Tramadol, another opioid painkiller, was also mentioned in the most recent FDA warning. That can cause the level of narcotics in the bloodstream to rise too high and too quickly, risking overdose in children, due to their smaller size. For children ages 12-18, and for breastfeeding mothers, the FDA said, the use of these medications should be limited.

"We require these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism)", said Douglas Throckmorton, deputy director at Center for Drug Evaluation and Research. A new Contraindication is being added to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

Tramadol is a prescription drug that is only approved to treat pain in adults, the agency noted. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding women due to the possible risk to their babies.

The warnings will only apply to prescription drugs; some products with codeine are available over the counter.

A review of medical literature for data regarding the use of codeine in nursing mothers found several cases of excess sleepiness and serious breathing problems in breastfed infants, including 1 reported death.

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Almost 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and almost 167,000 were prescribed a medication containing tramadol, the FDA said.

Parents should also discuss alternative pain medications for their kids with their doctors, as well as effective cough and cold remedies that do not contain opioids, the FDA said.

At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, "My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them".

For more on opioid medications in children, visit the Boston Children's Hospital.

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