In the year after drugmakers removed over-the-counter cough and cold medications for infants and toddlers from shelves, emergency room visits for kids under age two linked to overdose and adverse events were halved. In a study in the current issue of Pediatrics, CDC researchers looked at the number of visits to a random sample of 63 emergency departments in the 14 months before and after the October 2007 market withdrawal of cough-and-cold meds for children under the age of 12. Though the information about the specific formulation of cough-and-cold med was not available in all cases and limits the conclusions about specific products, the findings are evidence that such a preventive public health campaign can have significant impact.
Meanwhile we are awaiting new FDA dosing guidelines this month for OTC pediatric cough and cold meds; the guidelines were due out this summer but were delayed.
Drugmakers pulled multi-symptom cough-and-cold meds for infants and toddlers in Oct. 2007 and more in 2008 after pressure from a citizen petition filed by then-Baltimore Health Commissioner Joshua Sharfstein and other pediatricians, demanding that the FDA visit the safety requirements and standards for over-the-counter (OTC) pediatric cough and cold medication. Such medications, marketed for children, are not subject to any required efficacy standards and have been linked to infant deaths.
The agency responded by recommending that children under 2 not be given OTC cough and cold meds and formally reviewing its standards. In 2008, makers of those products voluntarily changed labeling to suggest such drugs not be administered to children under 4. The rest of the story, as they say, is that Dr. Sharfstein was since named principal deputy commissioner at the FDA.
Pediatrician Andrew Racine told Healthday the concerns are the same today as they were when Sharfstein and others filed the petition: "The efficacy studies for these things are not very robust, and the potential bad effects have been well-documented," he said.
Although cough-and-cold meds constitute a relatively small portion of emergency room visits for children under age 12, the authors write, "the safety concerns they have raised demonstrate how public-private collaborative efforts and a combination of education, engineering, and enforcement strategies can be used to improve medication safety in the outpatient setting."
--Kate Petersen, PostScript blogger