FDA further restricts pain medication use in kids
Another new warning to codeine and tramadol labels recommends against their use in adolescents between 12 and 18 who are obese or have other conditions that might affect their breathing, such as lung disease or sleep apnea.
Some children and adults are genetically predisposed to process opioid drugs more quickly, the FDA said.
On Thursday, FDA said that some children are at higher risk of harm from the medicines because they break down codeine and tramadol more rapidly than normal, which can cause dangerously high levels of the drugs in the blood. Tramadol is not approved for any uses in children, but it is commonly prescribed off-label to children anyway.
In a report published a year ago 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".
Codeine and tramadol are opioid medications used to treat pain.
The FDA is now warning against children under 12 taking either codeine or tramadol.
Since 2013, FDA notes, prescription codeine labels have contained a boxed warning and contraindication for children up to age 18 years of age regarding the risk of life-threatening respiratory depression following the use of codeine for pain management after the removal of the tonsils and/or adenoids. Codeine labeling already warns against post-surgical use for kids.
The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be unsafe to youth between 12 and 18.
"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said.
Almost 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and almost 167,000 were prescribed a medication containing tramadol, the FDA said.
The FDA officials also urged parents to check the ingredients of over-the-counter medications and to be extremely careful of giving children any that contain codeine. "They are powerful, effective medicines when used right [but] they can cause a lot of harm when they're not". They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.
In the body, opioid painkillers and cough medicines are broken down into morphine.
"We understand there are limited options when it comes to treating pain and cough in children", Throckmorton said.