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

Saturday, October 24, 2009

Infant Deaths Assoicated with OTC cough and Cold Medicaitons in Infants.

Between 2004-2005 there have been neglects of mislabeling that has lead to an estimated 1500 deaths in children 2 years and younger. The CDC and National Association of Medial Examiners did an investigation of U.S. infants aged 12 months and younger with the association of cough and cold medications. The report showed substantial evidence for causes of death in infants due to cough and cold medications. In the report the death of  three infants, ages ranging from 1 to 6 months, was due high levels of pseudoephedrine (a nasal decongestant) in the post mortem blood samples. Their blood levels of pseudoephedrine ranged from 4743ng/ml to 7100ng/ml. One of the infants had received a double dose of otc cough and cold medication and a prescription. The other two infants had a high blood level of dextromethorphan and acetaminophen. All three infants were found dead in there homes. The Medical Examiner determined that cough and cold medications was the cause of death for each of the three infants.



Cohen A, Shehab N, Srinivasan A.(2007 January 12).Infant Deaths Associated with Cough and Cold Medications--Two States 2005. MMWR weekly 56(01), 1-4.  Retrieved from the MMWR website: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm
Posted by Pharmacology Blog at 3:41 PM

1 comment:

  1. AnonymousOctober 29, 2009 at 1:10 PM

    Wow, I never thought cough medications could be this risky for kids.

    ReplyDelete

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