Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Adjusts Warnings Due To Codeine's Rare But Life-Threatening Side Effects On Kids
The Food and Drug Administration announced on Thursday that any child younger than 12 should not take the opioid codeine and that those 18 and younger should not take tramadol, another painkiller, after certain types of surgery. In addition, nursing mothers should avoid both opioids because they pose dangers to breast-feeding babies, the agency said. (Saint Louis, 4/20)
The Food and Drug Administration on Thursday warned parents against giving their children prescription medicines with codeine and tramadol, saying the drugs could lead to severe breathing problems and death. 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. The FDA also warned breast-feeding mothers to avoid using the medicines while nursing their babies. (McGinley, 4/20)
The finding comes after a safety review the FDA launched in 2015 to investigate the risks of these two opiate drugs. Presently, codeine is approved to treat pain and cough — including as a frequent ingredient in prescription cough syrups — and tramadol is approved to treat pain. (Sheridan,  4/20)
The federal agency said it identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18, in reports from 1969 through May 2015. The FDA said it also found nine cases of serious breathing problems, including three deaths, with the use of tramadol medicines in children under 18, from 1969 through March 2016. (Burton, 4/20)
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. (Hersher, 4/20)
"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." (Hersher, 4/20)
