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FDA Warning: Don’t Give Kids Codeine, Tramadol

1:45

The U.S. Food and Drug Administration (FDA) recently issued a warning about the dangers of two popular painkillers and the effects they can have on children. The government agency said that Codeine and Tramadol should not be given to kids under the age of 12 because they can cause life-threatening breathing problems.

Nursing mothers should also avoid using these drugs, since they can pass unsafe levels of opioids to their babies through their breast milk, the agency said.

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

"It's very hard to determine which child or mother has this risk, so that's why we've taken this action today," Dr. Douglas Throckmorton, deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said in a media briefing.

Codeine is often combined with acetaminophen in prescription pain medicines and cough syrups, while Tramadol is only approved to treat pain in adults, the agency said.

The FDA is now warning against children under 12 years old taking either codeine or tramadol.

Kids under 18 also should not be given tramadol to treat pain following surgery to remove the tonsils or adenoids, the agency noted. Codeine labeling already warns against post-surgical use for kids.

In particular, children with sleep apnea, are obese or who have a weakened respiratory system are at a higher risk for dangerous breathing problems from these two drugs.

"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence," Throckmorton said.

Both of these medications are often prescribed and are in households.  Nearly 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and nearly 167,000 were prescribed a medication containing tramadol, the FDA said.

Parents should carefully read drug labels to make sure medications don't contain either opioid, the agency stressed. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

"We understand there are limited options when it comes to treating pain and cough in children," Throckmorton said. "However, after careful review our decision to require these labeling updates was taken because we believe it is a way we can protect children."

The FDA plans to hold a public advisory committee meeting later this year to discuss the broader use of prescription opioid cough and cold medicine in children, he said.

Story source: Dennis Thompson, http://www.webmd.com/children/news/20170420/dont-give-kids-medicines-with-codeine-tramadol-fda#1

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