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tiptrot.com June 26, 2017


FDA further restricts pain medication use in kids

22 April 2017, 01:48 | Nichole Osborne

FDA Updates Restrictions of Codeine and Tramadol Use in Children, Nursing Mothers

FDA further restricts pain medication use in kids

Parents shouldn't give their children any medications containing the narcotics codeine or tramadol, because they can cause life-threatening breathing problems, the U.S. Food and Drug Administration warned Thursday.

Some children and adults are genetically predisposed to process opioid drugs more quickly, the FDA said.

FDA's review of adverse event reports submitted to the agency from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years.

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Now, labels for both codeine and tramadol are being updated to include additional Contraindications and Warnings; among the updates are Contraindications for use of codeine or tramadol in all children younger than 12 years of age, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers. Codeine labeling already warns against post-surgical use for kids. The new warning further limits the agency's previous restriction of codeine use in children younger than age 18.

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.

"We understand that there are limited options when it comes to treating pain or cough in children and that these changes may raise some questions for healthcare providers and parents", explained Throckmorton.


Nursing mothers who are taking codeine or tramadol can pass unsafe levels of opioids to their babies through breast milk.

Tramadol is a prescription drug that is only approved for adults to treat pain, the agency noted.

Regarding codeine use during breastfeeding, a literature search revealed numerous cases of respiratory depression and sedation, including one infant death, especially in mothers who have the CYP2D6 ultra-rapid metabolizer genotype.

FDA announced Thursday that it is restricting the use of codeine and tramadol medicines in children.

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".

Aside from breathing issues, codeine also causes nausea, vomiting, abdominal pain, constipation, and skin allergies.

For more on opioid medications in pediatrics, visit the Boston Children's Hospital. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids "are generally mild and go away in a few days, so they may not need to take any medicine".



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