Use of both codeine to treat pain and coughs and tramadol to treat pain are now both contraindicated in young children under the age of 12, said the FDA in a statement.
Products containing codeine or tramadol will now carry a "Contraindication" for children under the age of 12, which is the FDA's strongest warning. The agency cited concerns about slowed or difficult breathing or death, especially among younger children and infants in its decision to restrict the use of products containing these two drugs.
"We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies," said Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research, in a statement.
Throckmorton added in a media briefing that there is no way to know which children are “rapid metabolizers,†because it is genetically determined and varies by racial and ethnic group.
The FDA also added a new "Warning" advising against the use of products with codeine and tramadol in children ages 12 to 18 who are obese or have obstructive sleep apnea or serious lung disease. There is also a strengthened "Warning" advising against the use of these products among breastfeeding mothers, as it may cause serious harm to their infants.
The agency noted that , prescription products containing codeine have contained a boxed warning and contraindication for children and teens up to age 18 for pain management after removal of tonsils and adenoids. The same will now be true for tramadol-containing products.
"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 healthcare providers and parents," said Throckmorton. "However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe."
The FDA has been evaluating the use of codeine in cold-and-cough medicines in children since 2015 and the risks of using the pain medicine, tramadol, in children ages 17 and younger since September 2015. In 2016, the American Academy of Pediatrics issued a policy statement that advised against the use of codeine in all children.
The agency advised healthcare professionals that single-ingredient codeine and tramadol is only FDA approved for use in adults. Clinicians should advise parents to seek over-the-counter products or other FDA-approved prescription medicines to treat cold and cough in children under the age of 12 years.
At the briefing, Throckmorton described these new “labeling updates†as building on “our understanding of a very serious safety issue based on the very latest evidence.†He added that the FDA plans to hold a public advisory committee later this year to discuss the broader role of prescription cold and cough medicines in children, including those containing codeine.