Makers of pain medicines containing codeine and tramadol have been ordered by the FDA to make new labels banning under-12s from using their product
21 Abril, 2017, 01:41
The FDA also said breastfeeding women shouldn't take them because of possible harm to the baby.
Officials said they have been tracking reports about the drugs for years.
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. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe", said Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research. Tramadol is not approved for any uses in children, but it is commonly prescribed off-label to children anyway.
Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.
The FDA is now warning against children under 12 taking either codeine or tramadol. This new action further limits the use of these medications beyond the 2013 restriction of codeine use in children 18 years to treat pain after surgery to remove the tonsils and/or adenoids. Codeine labeling already warns against post-surgical use for kids. A search of the FDA Adverse Event Reporting System (FAERS) database from January 1969 to May 2015 identified 64 worldwide cases of respiratory depression, including 24 deaths, with codeine-containing medications in children 18 years old. Two years later, it issued two safety warnings about the drugs.
"Because we can't easily determine which children or nursing mothers specifically are at greater risk of ultra-rapid metabolism of codeine or tramadol, we are requiring manufacturers.to make important labeling changes to protect those children who are at the greatest risk", explains Throckmorton.
Multiple prescription drugs contain codeine or tramadol. The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed.
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.
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