The FDA review of several decades of adverse event reports submitted to FDA from January 1969 to May 2015 identified 64 cases of severe breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years, according to a press released.
Furthermore, the FDA also added that children ages 12 to 18 should also be warned against the use of medicine codeine or tramadol.
Tramadol is a prescription drug that is only approved to treat pain in adults, the agency noted.
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.
The US Food and Drug Administration warned the public on Thursday regarding the use of certain medications containing narcotics. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.
Read the label to make sure the medicine doesn't have codeine or tramadol.
Since it's almost impossible to identify the "ultrarapid metabolizers" or who may be especially sensitive or at higher risk of adverse events from the said opioid medications, the FDA now calls for stringent labeling requirements for manufacturers of codeine- or tramadol-containing drugs.More news: Meteor Shower To Light Up Weekend Sky
In its statement, the FDA has rounded up a list of codeine-containing drugs to watch out for - such as codeine sulfate, codeine phosphate, Butalbital, Acetaminopen, Tylenol, Promethazine, Prometh VC, Triacin-C, Tuxarin ER, and Tuzistra-XR.
Moreover, in order to counter pain and coughing, parents are advised to discuss alternative pain medications for their children with their doctors.
"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.
Both opioid medicines are in some cough and cold remedies, and were commonly prescribed by doctors and dentists despite the risk of life-threatening breathing problems in children. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe".
Regarding codeine use during breastfeeding, a literature search revealed numerous cases of respiratory depression and sedation, including one infant death, especially in mothers who have the CYP2D6 ultra-rapid metabolizer genotype.
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. Codeine products are available by prescription and, in some states, over-the-counter (OTC).