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An FDA committee will review prescription opioid products containing hydrocodone or codeine to treat coughs in children.
An FDA committee will review prescription opioid products containing hydrocodone or codeine to treat coughs in children, FDA Commissioner Scott Gottlieb, MD, said on Monday.
“It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions,” Gottlieb said in a statement from FDA.
Sometimes children’s cough symptoms can be severe enough that prescription medication is needed, “but some of these medications pose their own risks – especially for younger children – because they may contain opioids,” Gottlieb said. “Other times, medication might not be necessary at all.”
FDA’s Pediatric Advisory Committee will meet to discuss the issue on September 11 and 12 in Washington, D.C. The meeting is open to the public.
FDA said in April that it is restricting the use of codeine and tramadol medicines in children. The drug’s labels 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.
In addition, at a roundtable earlier this year, the FDA heard from the American Academy of Pediatrics, the American Academy of Family Physicians and other groups about the use of opioid cough suppressants, in children.
“Some of the key points focused on determining the right treatment based on the length and severity of the symptoms, as well as treating what’s causing the symptoms, rather than just quieting the cough. And depending on the situation, representatives suggested that other medications or non-drug therapies may be more appropriate,” Gottlieb said.
Related: FDA requires warning on opioids
FDA has also provided tips for consumers on how to safely treat a child’s cold as most young children do not need medicines to treat a cough or cold. “Caregivers should read labels on non-prescription cough and cold products that may be sold over the counter as these products may contain codeine or may not be appropriate for young children,” Gottlieb said.
FDA is also funding research to develop comprehensive, consumer-centered approaches on best practices for the safe use of pediatric cough and cold medications generally-not just those that contain an opioid.
“All of this work is essential to reducing preventable harm from opioid-containing medications and keeping children safe. We look forward to a robust discussion at the meeting this fall and will continue to share updates with the public on the steps the agency is taking to address this important issue,” Gottlieb said.