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November 1, 2007

Should We Treat Colds In Children?

Analysis of: Cough-Medicine Dilemma Widens | online.wsj.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Tim Gallagher, RPh, Executive Vice President of Pharmacy Operations Tim Gallagher, RPh
Executive Vice President of Pharmacy Operations , Astrup Drug, Inc.
Implications: An FDA advisory panel recently voted to stop the recommendation of otc cough and cold products in children less than 12 years of age. For decades parents have administered otc cough and could products to infants and young children. Even the FDA Advisory Committee had dissention amongst their members, voting 13 to 9 in favor of the change in the long standing treatment protocol of children's colds.

Analysis: For years we as healthcare professionals have recommended, when appropriate, certain otc medications for the treatment of the common cold.

Recently, the FDA Advisory Panel voted unanimously to stop the marketing of otc cough and cold products to children under the age of 2. There have been approximately 120 deaths in infants over the last 40 years attributed to the inappropriate use of otc decongestants and antihistamines. Discontinuing the use of these products in that age group is certainly appropriate. However, to say that no child under the age of 6 should receive otc medications for the treatment of cough and cold symptoms seems unreasonable.

While there may be no clinical studies to prove the efficacy of such products in that age group, we cannot infer lack of efficacy from lack of evidence in this case. Millions of parents have safely and effectively treated their children with otc cough and cold products for decades.

We all know that colds are self limiting and will resolve without treatment over time. We are not talking about curing colds, we are talking about treating symptoms. In my estimation it is certainly rational to use otc cough and cold products appropriately upon the consultation of a physician or pharmacist.

If these products are removed from the market or the dosage recommendations are changed to reflect only the treatment of adults and children over the age of 6, parents will not stop using the products.
Instead, parents and caregivers will attempt to determine dosing for children based on their "best guess" by interpolating adult dosing. This is a course we should not take.

Other Analyses of the Same Source Article:
We don't treat colds, we treat children
November 1, 2007, Author: GLG Expert Contributor

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