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The FDA and Cold Medicines for Children – Part II

According to a Washington Post article today, here (for now), federal officials are now recommending that “consult your physician” be dropped from guidelines on boxes of cold/cough medicine for children under two.  These medicines, in many cases, simply should not be given to young children.  “The preliminary recommendation, from Food and Drug Administration safety officials would apply to decongestant use in children under 2 and antihistimines in those younger than 6, according to agency documents released Friday.”

More than 350 pages of documents were released on Friday.  They are part of a broad investigation into whether roughly 800 medicines (yes, 800) are safe and effective in treating children’s colds and coughs.  Many of those medicines are popular and widely used.

“An FDA review of side-effect records filed with the agency between 1969 and September 2006, found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine.”  In addition, a Centers for Disease Control and Prevention report also found more than 1500 toddlers and babies wound up in ERs in a two-year period as a result of the medicines.

The Consumer Healthcare Products  Association (represents makers of OTC medicines)  is backing the recommendation that these products not be given to young children and in terms of antihistamines, they recommend that a warning be added that the medicines not be used to sedate children.

How sad is it that you have to add a warning about that?  And really, do they think that the types of people that would use it for that purpose would care whether there is a warning on the box or not?  It seems to me that the only purpose for that warning is for legal purposes for themselves.  I admit that I’ve wondered about how effective these medicines have been on my two-year-old, but he’s rarely (thank goodness) sick so it hasn’t come up much.  He has taken an antihistimine occasionally, on the recommendation of his doctor, so I wonder about that part of the article as well.  I’m going to have to talk to his doctor about this next time I go in (or rather, next time WE go in).

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