What's the Deal with OTC Cough & Cold Medications for Infants?: Myth or Fact?

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

Thursday, October 22, 2009

Myth or Fact?

Do cough medications really work on children? If not, how to manage Cough in children?

Cough and cold are common problems among children due to viral infections. Many parents overlook the fact that when they walk to a local drug store and pick up an over the counter cough or cold medicine, they are overlooking the underlying reasons of why their children are having cough and cold? According to Kelly LK and Allen PJ, in their journal “Pediatric Nursing” many of those parents who choose over the counter cough and cold medications for their children need to rethink. According to them “the stated actions of some combination cough preparations are contradictory” and many cough medications are advertised as “multi-symptom”.

Studies done by Paul, Yoders, et al. (2004) show that OTC cough and cold medications do not help children to relieve their symptoms but only suppress the cough and cold, however they add to side effects and adverse reactions to the child’s body due to dosing errors. In 2002 the Food and Drug Administration suggested phenypropanolamine used in OTC cough and cold medications to be removed from the market due to its adverse effects to the cardiovascular system such as stroke, intracerebral hemorrhage, and high blood pressure.

If OTC cough and cold medications are not a good way to treat our sick children, how do we manage cough and cold in young children then?

References

Kelley, L., & Allen, P. (2007). Primary care approaches. Managing acute cough in children: evidence-based guidelines. Pediatric Nursing, 33(6), 515-524. http://libproxy.uta.edu:2066