FDA Scrutinizing Kids’ OTC Cold Remedies
There have been many reports today, most saying basically the same thing, Here are two that cover the issue.
Report: FDA Eyes Kids’ Cold Drugs - Forbes.com
Warnings sought on kids’ cold medicine - Yahoo! News
The cause of this was a filing by Baltimore health authorities and others yesterday (Mar 1, 2007). A recent report from the Center for Disease Control that noted 1,500 toddlers and babies had been taken to the emergency room because of over the counter cough and cold remedies over a two year period. And the medical examiner in Baltimore noted that at least four children under the age of four have had their deaths linked to these products over a five year period.
None of these products are recommended for children younger than two and all state that it should not be used except under the advice of your doctor. But the report says that many products contain the name “infant” or “baby” such as “baby aspirin”. These along with pictures of mothers holding infants and other children much younger than two are shown in the packaging.
I personally think the warnings are adequate but that some of the pictures and wordings in the packaging should be changed so as to not be misleading. I’d like to see the OTC industry do this voluntarily but I don’t think that will happen. And I don’t think the FDA is likely to step in and require that. It is much more likely in my opinion for the FDA to issue a statement saying that these products should not be used in children younger than two without instruction from their doctor.
This does bring up the bigger issue of how do you determining the proper dosing of these OTC products in children? Most data is from extrapolation of adult data and may not be appropriate to children. THis is really the bigger question and one for which there is no answer currently.
Technorati Tags: drug safety, pediatric drugs
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