In addition, a new Warning is being added to the drug labels of codeine and tramadol to recommend against their use in adolescents between aged 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
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.
To view the full article, register now. Codeine products are available by prescription, with some states allowing the drug to be sold over the counter.
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. Codeine is often combined with acetaminophen in prescription pain medicines and cough syrups, the agency said.
FILE - In this photo taken October 14, 2015, file photo, the Food & Drug Administration campus in Silver Spring, Md.
The agency on Thursday ordered several alternations in labels to underscore the risks of the drugs to children. In 2013, the agency restricted use of codeine in children to treat pain after surgery to have tonsils and adenoids removed. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine.
Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research said in a statement that they have discovered that some children who take medicine containing codeine or tramadol have experience life-threatening respiratory depression and even death.
"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".
"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said.
Dr. Thomas Green, co-author of the American Academy of Pediatrics report advising against codeine use, said these prescriptions, "are just very risky, especially for kids". The same will now be true for tramadol-containing products. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids "are generally mild and go away in a few days, so they may not need to take any medicine". According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.