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

Tuesday, October 20, 2009

A physicain's view on cough medication.

Back in 2007, Dr. Michael Shannon, MD, who works at Children's Hospital Boston, spoke to a panel of peers and board members on the dangers of cough/cold medication.  He points out that the medication can be especially detrimental to infants that are less than two years old.  He also states that some of the blame should be directed to the parents and caretakers that neglect to correctly read labels, but the brunt of the blame was directed towards the medication companies that do not regulate testing of the medicine in younger children.





The three main factors that Dr. Shannon states that poses the most problems are wrong dosage amounts, adverse drug interactions, and underlying illnesses.


Reference:
Shannon M. (2007 Oct. 31) Dr. Michael Shannon on cold medications. Childrens Hospital's Boston Channel News.Retrieved Oct 16, 2009 from http://www.youtube.com/watch?v=DwOYu16hpfw
Posted by Pharmacology Blog at 10:18 AM

5 comments:

  1. AnonymousOctober 28, 2009 at 2:55 PM

    This is a very interesting read, I did not know that the effects of medicine was that big of a deal on children of young age and babies. This article helps shine light on why standards should be clearly set in regards to babies and young aged children of 5.

    ReplyDelete
  2. JonathanOctober 28, 2009 at 7:55 PM

    I think that most people are too careless when they read labels, and they think that the instructions aren't that big of a deal. You should ask a doctor before medicating a child that young, in the first place. Secondly, if they label says for children 6 and older, and your child is 3...

    ReplyDelete
  3. UnknownOctober 28, 2009 at 7:56 PM

    Yeah that is the reason why some parents need to stop being ignorant, and feed their children any medication that they can get their hands on.

    ReplyDelete
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