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

Friday, October 23, 2009

Making Assumptions Could Cost Lives

I remember when i was a kid and I got any kind of cough or cold, my parents would simply give me some kind of OTC cough or cold medication numerous times of the day depending on how sick i was. This is the case with many parents today. Many parents simply seem to pick up OTC cough or cold medications from their local drug store thinking that the labels work well for their children below 2 years of age. However, misinterpretations of the labels on the OTC drugs could cost serious complications in children. In the "Morbidity and Mortality Weekly Report (2007)" presented by Centers for Disease Control and Prevention, in the 2004 -2005 around 1,519 children less than 2 years of age were rushed to the emergency departments due to the adverse reactions of the OTC cough and cold medications provided by their caregivers. The problem is not with the medications, the problem is with the dosage of those OTC drugs. For this age group, FDA approves no dosage recommendations as studies are still being done to prove whether these drugs really help children under the age of 2. Due to the high risk of toxicity in children, caregivers should always be careful in treating cough and cold with OTC drugs in their children. Dosage and combination of drugs with the same drugs can cause serious and adverse side effects in their children which can be fatal.




Sources:


American Psychological Association.(2007). Infant deaths associated with cough and cold medications--two states, 2005. MMWR. Morbidity And Mortality Weekly Report, 56(1), 1-4.retrieved from: http://libproxy.uta.edu:2066
Posted by Pharmacology Blog at 8:49 AM

1 comment:

Subscribe to: Post Comments (Atom)