FDA Warning: Codeine Cough Syrup, Tramadol Can Kill Kids Under 12

FDA Warning: Codeine Cough Syrup, Tramadol Can Kill Kids Under 12

FDA Warning: Codeine Cough Syrup, Tramadol Can Kill Kids Under 12

On Thursday, the U.S. Food and Drug Administration warned that Parents shouldn't give their children medications containing the narcotics codeine or tramadol.

Labels for both codeine and tramadol are being updated to include additional "Contraindications and Warnings". The FDA also says breastfeeding women shouldn't take them because of possible harm to the baby.

Officials said they have been tracking reports about the drugs for years.

He said that "ultrarapid metabolizers" process the drugs much faster than usual, resulting in dangerously high levels that can depress breathing and lead to death. 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 approved only to treat pain in adults, but data show it is being used in children and adolescents, the FDA said.

In a report published past year 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". Codeine also is used in cough syrup and cold remedies and sometimes is combined with other medications, such as acetaminophen.

The agency in 2013 had warned against use of codeine and tramadol in children and adolescents to treat pain after surgery to remove tonsils.

From then until May of 2015, the agency identified 24 deaths and 40 other cases of serious breathing problems in children under 18 taking medicines containing codeine. Two years later, it issued two safety warnings about the drugs. 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.

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

In the body, opioid painkillers and cough medicines are broken down into morphine.

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