Medical advisers to the Food and Drug Administration say that prescription drugs containing codeine should not be used to treat children or the majority of teens suffering from pain or a cough.
In their meeting Thursday, the advisers also voted overwhelmingly against the over-the-counter sales of codeine-containing cough syrup for children. Selling such products without a prescription is currently permitted in 28 states and the District of Columbia.
The votes to restrict codeine’s use among children came at the end of a daylong joint meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, in Silver Spring, Md. The FDA does not have to follow the recommendations of its advisory committees, but it usually does.
“My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them,” said pharmacist Maria Pruchnicki, of the Ohio State University College of Pharmacy. […]
Also, representatives from the American Academy of Pediatrics and the National Center for Health Research, an advocacy group in Washington, D.C., urged the FDA to follow the lead of regulators in Europe, Australia and Canada, who have sharply restricted the drug’s use. […]
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To read NCHR’s testimony, click here.