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

Sunday, October 25, 2009

Voluntary Withdrawl of Infant Cough, Cold Medications by Drug Makers

On August 15, 2007, the FDA issued a health advisory report warning parents not to give over the counter cough and cold medications to children under the age of 2. This recommendation is due to autopsy confirmed infant deaths directly related to complications from taking cough and cold medications. Following this discovery on October 11, 2007, the Consumer Healthcare Products Association (CHPA) announced on behalf of various drug maker and distributors the voluntary withdrawal of their over the counter infant cough and cold medications. 


The following is a list of branded infant cough and cold medication that were voluntary pulled from the market:

Dimetapp Decongestant Plus Cough Infant Drops
Dimetapp Decongestant Infant Drops
Little Cold Decongestant Plus Cough
Little Colds Multi-Symptom Cold Formula
PEDIACARE Infant Drops Decongestant
PEDIACARE Infant Drops Decongestant & Cough
PEDIACARE Infant Dropper Decongestant
PEDIACARE Infant Dropper Long-Acting Cough
Robitussin Infant Cough DM Drops
Triaminic Infant & Toddler Thin Strips Decongestant
Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough
TYLENOL Concentrated Infants Drops Plus Cold
TYLENOL Concentrated Infants Drops Plus Cold & Cough


The CHPA president Linda Suydam stated in a news release that the voluntary action was not due to the ineffectiveness or safety of the medication, but due to the trend of over use and abuse of the medications that led to over dosing infants on these drugs. The medications were effective and safe taken at the recommended dose.

Smith, M. (October 11, 2007). Infant Cough, Cold Drugs Withdrawn. Retrieved from http://blogs.webmd.com/healthy-children/2007/10/infant-cough-cold-drugs-withdrawn.html
Posted by Pharmacology Blog at 5:31 PM

5 comments:

  1. UnknownOctober 28, 2009 at 7:58 PM

    I just feel like there's always going to be something that goes wrong when it comes to medication. Obviously when something unnatural is introduced into millions of people who all have variations in genetic makeup (which means everyone has different proteins), someone is bound to get affected in the wrong way.

    ReplyDelete
  2. UnknownOctober 28, 2009 at 7:59 PM

    Moderation. Need I say more!?!

    ReplyDelete
  3. UnknownOctober 28, 2009 at 8:06 PM

    I just feel that people need to be more careful with their children and not take thing so lightly when it come to their children health.

    ReplyDelete
  4. AnonymousOctober 29, 2009 at 1:20 PM

    same with the person above me said, if it was my child I would take them to the doctors instead of running to the store and grabbing some cheap stuff off the counter.

    ReplyDelete
  5. AnonymousOctober 29, 2009 at 6:54 PM

    This is invigorating and has open my eyes to the new meaning of medicine. If it were m child I'd go to the doctor and get their advice first then take action in selecting which medicines to use.

    ReplyDelete

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