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

Parents just don't know.

A study conducted by various pediatricians from September 1, 2006 to October 16, 2007 shows the flaw in parental care when it comes to OTC cough/cold medicines.  The most startling evidence of dosing negligence was that of the 182 parents of infants less than two years old tested, 50% of the parents would give cough/cold medicine to their child due to misinterpretations of pictures, labels, and dosing instructions.


Reference

L. M. Sanders, J. S. Shaw, G. Guez, C. Baur, and R. Rudd. Parental Misinterpretations of Over-the-Counter Pediatric Cough and Cold Medication Labels. Pediatrics, November 1, 2009; 123: 1464-1471 
Posted by Pharmacology Blog at 4:25 PM

2 comments:

  1. AnonymousOctober 29, 2009 at 1:13 PM

    Now I know better when I start having kids.

    ReplyDelete
  2. TINA PHILIPASeptember 8, 2019 at 6:17 PM

    I am very much happy to share to every viewers that is reading this,I want to inform the whole public of how I got help for my herpes, I wanted this since 6 months ago, I have also taken treatment from some doctor,few weeks back I came on the net to see if I will be able to get any information as to cure my herpes, on my search I saw various testimony of people who was helped by a great man called Dr Akhigbe and without any hesitation, I contacted him, I wrote to him and and he guided me, I asked him for solutions and he started the remedies for me and indeed 3 weeks after I started using the medicine, I was completely happy as it worked for me.I went to the hospital for check up and indeed I was declared negative from my disease, and I also waited again for two weeks and went back to another hospital for check up to be fully sure and to my great surprise I was still declared negative, and I decided to share this great opportunity to those people out there fighting this sickness, You can contact him now for your medicine to cure your diseases, contact his Email; drrealakhigbe@gmail.com or Whatsapp +2348142454860.   website. hpps:drrealakhigbe.weebly.com
    Dr  Akhigbe also cure diseases like..
    HIV
    Herpes
    CancerChronic DiseaseAsthmaParkinson's diseaseExternal infection
    Als,common coldmultiple sclerosis diseaseNausea, Vomiting or DiarrheaHeart Disease
    DiabetesKidney DiseaseLupusEpilepsyStrokeEczemaEating DisorderBack Pain. etc
    contact him for your solution.

    ReplyDelete

Subscribe to: Post Comments (Atom)