Don't Give Kids Meds With Codeine, Tramadol: FDA

The FDA is requiring tough new warnings on cough medicines and other drugs containing codeine or tramadol

The U.S. Food and Drug Administration (FDA) Thursday advised against the use of two narcotic painkillers - codeine and tramadol - on children under 12 and nursing mothers.

We are requiring 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), causing dangerously high levels of active drug in their bodies.

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

In a report published a year ago in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., "neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown".

The agency on Thursday ordered several alternations in labels to underscore the risks of the drugs to children.

Tramadol is available only for adults and by prescription to treat pain.

The agency said that a safety review of adverse events reports submitted to the FDA from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, involving codeine-containing medicines in children younger than 18.

Youths ages 12 through 18 who are obese or have obstructive sleep apnea (blocked airflow during sleep) or a weakened respiratory system shouldn't take codeine or tramadol.

"Maybe a little pain is better than the alternative", Cote said.

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.

"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", said Throckmorton. As a result, the American Academy of Pediatrics issued a policy statement warning against the use of such medicine on kids in 2016, claiming that using such medicine can result in serious breathing problems.

For more on opioid medications in children, visit the Boston Children's Hospital. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol. If a codeine-or tramadol-containing product is determined to be appropriate for an adolescent patient, clinicians should provide counseling on how to recognize the signs of opioid toxicity.

The FDA officials also urged parents to check the ingredients of over-the-counter medications and to be extremely careful of giving children any that contain codeine.

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