he FDA issued its strongest level of drug warnings Thursday concerning opioid pain-reliever use in children.
Medicines containing codeine and another narcotic, tramadol, will now require a label indicating that they should not be used by children under 12. For children ages 12-18, and for breastfeeding mothers, the FDA said, the use of these medications should be limited.
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.
The analysis found that the drugs carry serious risks for patients under the age of 12, including difficulty breathing and death, and that they carry a risk for adolescents up to age 18 who have breathing troubles.
“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. 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 Dr. Douglas Throckmorton, the FDA’s deputy center director for regulatory programs, in a written statement.
Codeine already carries a black-box warning, which the FDA added in 2013, stating that the medication should not be used to treat a child’s pain after surgery to remove his or her tonsils. Tramadol will now also bear this warning in addition to the other new contraindications and warnings.
The warnings will only apply to prescription drugs; some products with codeine are available over the counter. The FDA is also considering other regulations that would apply to over-the-counter codeine products.
Both Health Canada and the European Medicines Agency have issued similar warnings about codeine within the past five years. Canadian regulators also recently completed a safety review for tramadol with similar findings to the FDA’s.
Unlike codeine, tramadol wasn’t FDA-approved for pediatric patients; however, in September 2015, the agency noted it was likely being used off-label in children.
The American Academy of Pediatrics encouraged doctors to stop giving codeine to children in a September 2016 report published in Pediatrics.