In a report published previous year in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., "neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown".
In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids.
Warning labels on medications with codeine or tramadol will be strengthened to reflect these potential dangers, the FDA said in a statement.
Douglas Throckmorton, a top official at the FDA's Center for Drug Evaluation and Research, said in telephone briefing for reporters that the safety hazards are the result of the "unique way" these medications are broken down in the bodies of some children and adults.
Children metabolize these medications much faster than adults, which can cause the active ingredients to rise in their bloodstreams to dangerously high levels, the agency said.
The FDA is now warning against children under 12 taking either codeine or tramadol.
The FDA added a "Black Box" warning against using codeine to treat children with tonsillectomy pain in 2013.
"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said. Besides a change saying that the drugs shouldn't be used in children under 12, the mandated changes include a new warning for tramadol saying it shouldn't be used in children younger than 18 for post-surgical pain after the removal of tonsils and adenoids. For example, the painkiller Tylenol 3 contains acetaminophen and codeine.
The FDA plans to hold a public advisory committee meeting later this year to discuss the broader use of prescription opioid cough and cold medicine in children, he said.
"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". The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed. "However, after careful review our decision to require these labeling updates was taken because we believe it is a way we can protect children".