FDA is restricting the use of codeine and tramadol medicines in children. The drug’s labels will now include a contraindication that codeine should not be used to treat pain or cough, and that tramadol should not be used to treat pain, in children younger than 12 years.
“We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies,” said Douglas Throckmorton, MD, deputy center director for regulatory programs at FDA’s Center for Drug Evaluation and Research, in a FDA statement.
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“This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease,” Thockmorton added.
FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
“Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk,” Throckmorton said.
FDA is adding a new contraindication to the tramadol label, warning against its use in children younger than aged 18 years to treat pain after surgery to remove the tonsils and/or adenoids. In addition, a warning will be added to codeine and tramadol labels, recommending 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.
“Health care professionals should be aware that tramadol and single-ingredient codeine medicines are FDA-approved only for use in adults. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems,” FDA said in a statement. “Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary.”
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