FDA Issues Multiple Restrictions on Codeine, Tramadol Use

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.

The agency said it would require manufacturers to make label changes to warn that the drugs shouldn't be used for anyone under 12 and should be restricted in older children. Respiratory depression can also occur in nursing babies when mothers who take codeine and tramadol and pass it along to their children through their breast milk.

A new contraindication to the tramadol label warning against its use in children younger than 18 years old to treat pain after surgery to remove the tonsils and/or adenoids.

FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers.

Regulators in Europe, Canada and Australia have all restricted the use of medicines containing codeine for children.

The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use. The agency is now adding a Contraindication to the drug labels of codeine and tramadol warning that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.

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Children and teens ages 12 to 18 shouldn't take them if they are obese, have obstructive sleep apnea or a weakened respiratory system. Tramadol will now also carry a similar warning label.

The FDA has been reviewing the safety of codeine and tramadol for a few years, including combing through reports about patients harmed dating to 1969. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe". It is frequently combined with other drugs in prescription and over-the-counter (OTC) cough and cold medicines.

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. These signs include slow or shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness.

"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. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

The FDA recommends that parents talk to a doctor before giving their children such drugs.


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