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

Monday, October 26, 2009

Things to know before giving your child otc medications

To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the "Drug Facts" box on the package label.
Here's what parents should know about using cough and cold products in children:
* Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.
* Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children, sometimes called "pediatric" use.
* Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a healthcare provider.
* If other over-the-counter or prescription medicines are being given to a child, the child's healthcare provider should review and approve their combined use.
* Read all of the information in the "Drug Facts" box on the package label so that you know the active ingredients and the warnings.
* Follow the directions in the "Drug Facts" box. Do not give a child medicine more often or in greater amounts than is stated on the package.
* Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger. Do not give medication 2 years and younger
* For liquid products, parents should use the measuring device, such as the dropper, dosing cup or dosing spoon, that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.
* If a measuring device is not included with the product, parents should purchase one at the pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the "Drug Facts" box on the package label, or is recommended by the child's health care provider.
* If you do not understand the instructions on the product, or how to use the dosing device, such as the dropper, dosing cup or dosing spoon, do not use the medicine. Consult your healthcare provider if you have questions or are confused.
* Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.
* If a child's condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.

Reference:

Yeaton A. (2007 August 17).Nonprescription Cough and Cold Medicine use in Children.Retrieved website from: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm078927.htm
Posted by Pharmacology Blog at 7:22 PM

3 comments:

  1. AnonymousOctober 28, 2009 at 8:18 PM

    Thanks for the info! Being a new mother, you want to take extra precautions in caring for your little one when they're ill. This definitely proves useful...

    ReplyDelete
  2. UnknownOctober 28, 2009 at 8:24 PM

    This makes sense. If your child is under 6, take them to a freakin pediatrician...period.

    ReplyDelete
  3. UnknownOctober 28, 2009 at 10:02 PM

    I agree. Once I have a child I will remember this info for future reference.

    ReplyDelete

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