“The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be dangerous to youth between 12 and 18.
On Thursday, the FDA said it will require that prescription drugs containing codeineor tramadol carry a warning on the label against using them in children under 12 or in women who are breast-feeding. The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death.
Multiple prescription drugs contain codeine or tramadol. For example, the painkiller Tylenol 3 contains acetaminophen and codeine. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.
“This is something we’ve been watching for several years,” says Douglas Throckmorton, the deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research. “They are powerful, effective medicines when used right [but] they can cause a lot of harm when they’re not.”
The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.
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. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids “are generally mild and go away in a few days, so they may not need to take any medicine.”
Thursday’s announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.
At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR’s Rob Stein, “My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them.”