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FDA evaluating prescription opioid medications for children

August 25, 2017
by Tom Valentino, Senior Editor
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FDA Commissioner Scott Gottlieb, MD, this week announced a meeting of the agency’s Pediatric Advisory Committee on Sept. 11 to discuss the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients. Discussions will cover current treatment practices and benefit-risk considerations.

“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 the statement. “This is an area the agency is continuing to evaluate.”

Professional groups, including the American Academy of Pediatrics and the American Academy of Family Physicians shared concerns about the use of cough suppressants, particularly opioid cough suppressants, during a roundtable discussion with the FDA earlier this year. Representatives on the panel recommended other medications or non-drug therapies may be more appropriate.

In April, the FDA announced changes to labeling requirements for prescription codeine products to better protect children from serious risks, and has also published guidelines on how consumers can safely treat children’s colds without the use of medicine.

Overall, the FDA has made a broad push to more closely scrutinize the use of opioids this year. In June, the agency also requested that Endo Pharmaceuticals voluntarily remove its Opana ER (oxymorphone hydrochloride) drug from the market because of the growing incidents of manipulation and misuse.