The FDA has contraindicated the use of codeine to treat pain and coughing and Tramadol for pain in children under the age of 12.
Codeine and Tramadol will now carry a "Contraindication" for children under the age of 12 which is the FDA's strongest warning. They cited concerns about slowed or difficult breathing and even death, especially among younger patients.
"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.
Because it is genetically determined and varies by racial and ethnic group there is no was to know which children are "rapid metabolizers". They also warned against using codeine and Tramadol in children ages 12-18 who are obese or have obstructive sleep apnea or serious lung disease. In addition, there is also a strengthened warning advising against the use of these medications in breast feeding mothers as it could cause harm to the infant.
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 medication, Tramadol, in children ages 17 and younger since 2015 as well. Parents are urged to seek over the counter or other FDA-approved medications to treat cold and cough in children under 12.
