FDA Determines Codeine, Tramadol Unsafe For Children

The Food and Drug Administration on Thursday sharply ratcheted up its warnings about giving children prescription medicines with codeine and tramadol, saying the drugs could cause severe breathing problems and death.

Warning labels on medications with codeine or tramadol will be strengthened to reflect these potential dangers, the FDA said in a statement.

Officials said they have been tracking reports about the drugs for years. 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. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe", said Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research.

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

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Numerous products containing these drugs are only available by prescription, but several over-the-counter cough medicines contain codeine.

Codeine and tramadol are opioid pain-relieves that also reduce coughing, usually along with acetaminophen or aspirin.

The FDA is now warning against children under 12 taking either codeine or tramadol. Codeine labeling already warns against post-surgical use for kids. The drugs can reportedly cause life-threatening breathing problems. The FDA said it is requiring makers of prescription versions of the medicines, codeine and tramadol, to change the products' labels to warn against giving them to children under age 12, and to limit use in older children.

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.

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The FDA will continue to monitor this safety issue and is considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines in children. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms.

"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 health care providers and parents".

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