The FDA also added a new "Black Box" warning label against using codeine or tramadol medicines in children aged 12-18 years old who are obese, have obstructive sleep apnea, or serious lung diseases.
The majority of serious side effects occurred in children younger than 12, sometimes after a single dose, the FDA said. The drugs can reportedly cause life-threatening breathing problems.
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Use of both codeine to treat coughs and tramadol to treat pain are now both contraindicated in young children under the age of 12, said the FDA in a statement. Others might metabolize codeine or tramadol too quickly. "This causes dangerously high levels of active drug in their bodies". They include the FDA's strongest warning, a "contraindication", specifying that tramadol should not be used in children who have had their tonsils removed.
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. These drugs should not be used in children younger than 12 years, FDA said, and should also be limited in some older children. The FDA also says breastfeeding women shouldn't take them because of possible harm to the baby.More news: Justice Dept threatens sanctuary cities in immigration fight
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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".
Codeine and tramadol are opioid medications used to treat pain. 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.
Atlanta pediatrician Dr. Maia Walton said she rarely prescribes opioid pain medications to her patients. In addition, the Agency is considering more regulation surrounding OTC codeine products that are available in some states.
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 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".