The Controversy of Over- the- Counter Cough and Cold Medication for Children
Imagine going to the drug store or your local supermarket and walking into the pharmacy aisle looking for over the counter cough and cold medications for your sick 3 year old child, you notice that on the labels of the cough and cold medications there are no dosing information for treating infants younger than 5 years of age. The current drugs are labeled for children 6 years and older. Why have all the labels changed and how come none of the drugs have dosing instructions for ages 5 year and younger?
The reason for this started around October 2006, a group of chief pediatrics from the Baltimore Area, the Maryland Chapter of American Academy of Pediatrics, Dr. Janet Serwint of John Hopkins and Baltimore City Health Department all joined together to issue an advisory to parents for over the counter cough and cold medications for children ages five and under. In recent years doctors have reported serious injuries and death, and studies have failed to show effectiveness in children. The group petitioned to the commissioner of the FDA to provide a statement to the public explaining that over-the-counter antitussive, expectorant, nasal decongestant, antihistamine and combination cough and cold products have not been shown to be safe and effective for the treatment of cough and cold in children under six years of age. And that they notify manufacturers of these products whose labeling uses such terms as “infant” or “baby,” or displays images of children under the age of 6 that such marketing is not supported by scientific evidence and manufacturers will be subject to enforcement action at any time. The FDA should also amend 21 CFR 341 to require that labeling for over-the-counter antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products state that these products have not been found to be safe or effective in children under 6 years of age for treatment of cough and cold and that these products should not be used for treatment of cough and cold in children under 6 years of age.
Sharfstein J. (2007 October 18).Over the Counter Cough and Cold Products for Children Under Age 6
Retrieved October 16 2009, from FDA's Website:
www.fda.gov/ohrms/dockets/ac/07/slides/2007-4323s1-03-Petitioner-Sharfstein.ppt - 2007-11-15
its good to always find alternatives
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