To the Editor.—

In the August 2008 issue of Pediatrics, Rimsza and Newberry reported a study intended to examine whether there is an association between over-the-counter (OTC) cough and cold medications and unexpected infant deaths in Arizona. The authors identified 10 deaths wherein toxicological evidence exists for recent administration of OTC cough and cold medications. Of the 10 cases, only 1 infant had been given medications after consultation with a health care provider. The current labeling for OTC products used to treat the symptoms of cold and cough does not have dosing instructions for children <2 years of age. Two infants were found to have been exposed to ambroxol (cases 5 and 10 listed in their Table 2), a mucolytic agent widely available without a prescription outside the United States. We emphasize that ambroxol is not approved for prescription or OTC use by the US Food and Drug...

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