PEDIATRICS Vol. 122 No. 6 December 2008, pp. 1413 (doi:10.1542/peds.2008-2497)
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LETTER TO THE EDITOR |
Unexpected Infant Deaths Associated With the Use of Cough and Cold Medications
Jeffery L. Chamberlain, MDAdvantage Health-Family Medicine
Grand Rapids, MI 49505
To the Editor.—
Thank you for publishing the article "Unexpected Infant Deaths Associated With Use of Cough and Cold Medications" by Rimsza and Newberry.1 There is growing evidence that the number of deaths and other adverse events associated with cough and cold medications in children are vastly underrecognized, and this research adds to the evidence. When a child comes into a doctor's office or emergency department with upper respiratory infection symptoms, tachycardia, nausea, vomiting, and fussiness, maybe we should start placing "over-the-counter cough and cold medication overdose" near the top of our differential.
As a dad and a doctor, I find this a very scary topic. If you extrapolate the 10 infant deaths associated with cough and cold medications from Arizona's population of 6 million, to the combined US and Canadian population of 337 million, the estimated deaths associated with cough and cold medications are >500 per year!
In October of 2007, members of the children's cough and cold drug industry promised the US Food and Drug Administration (FDA) and the nation that they would place on their dosing instructions "do not use" for children younger than 2 years of age. Last night I was at a national grocery/pharmacy, and of all the children's cold and cough medications that were on the shelf (and there were several), only 1 brand had "do not use" for children younger than 2 years of age printed on the label; the rest have not adopted wording this yet.
In October 2007 the FDA reviewed safety and effectiveness data on these medications, and a majority of its expert panel voted that on the basis of the current data, cough and cold medications should "not be used now in children under the age of 2," and they should "not be used for the common cold right now for children between the ages of 2 and less than 6." (www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4323m1-Final.pdf [see page 6]).
It is time that we stood up to the drug companies and tell our elected officials and the FDA that these medications need to be pulled from the shelves. This needs to come from the top down; the drug companies have already proven that they will not keep their promises. When a medication has been shown to be dangerous and has never demonstrated good evidence of efficacy, then we should not be giving it to children.
REFERENCE
1. Rimsza ME, Newberry S. Unexpected infant deaths associated with use of cough and cold medications. Pediatrics. 2008;122 (2). Available at: www.pediatrics.org/cgi/content/full/122/2/e318
PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics
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