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BLOG: November 2007

Children medications: danger, danger...

As more details surface about the ongoing FDA focus on over-the-counter children cough medications, there is only more reason for concern. How aware are we of the effects that these particular drugs - as well as others - can have on children's health, especially the little ones? How much do the manufacturers care? And - directly related - is there any meaningful accountability for anyone when something goes terribly wrong?

As reported by CNN, panel of FDA health experts decided this month that cold and cough medications don't work for children under the age of 6, and cannot be recommended. The recommendation is non-binding, which means the manufacturers don't have to change nothing in their marketing. Nevertheless, shortly before the FDA hearings, some leading manufacturers voluntarily withdrew more than a dozen cold medications for infants from the market.

This may have something to do with the FDA review of the past use of these medications, which has found

123 reported deaths

from decongestants and antihistamines since 1969, most of them children under 2. And, what actually has set the wheels in motion, was recent Dr. Joshua Sharfstein's (Baltimore Health Commissioner) public alarm after four Baltimore children died from apparently excessive dozes of cold medications. According to him, he wasn't aware before those tragic events that overdosing with this type of medications can have such serious consequences.

The question arises: if medical professionals haven't been aware of it, what chances would you and me have? The trap was set: cold medicine is ineffective, unless given in doses too strong for small children. So the parents, thinking that they are helping their little ones, were putting them at a terrible risk. But who was supposed to make sure that medications that can kill are not marketed as over-the-counter children cold medicine, something most people assume is about as harmless as sweetened water? Or, at least, that they are properly labeled, with clear warnings about potentially deadly effect?

That is, of course, rhetorical question. Who is - or should be - responsible is the manufacturer and, ultimately, the government, represented by the FDA. As it seems, neither will bear any consequences in this case. Like two accomplices, they'll play a little game with voluntary recalls, on one, and new proper labeling/dosage recommendations on the other side. Clean hands. The problem is that such irresponsible practices, and getting away with it, only make sure that

it will happen again.

Worse yet, that is happening right now, as it was happening for decades.

Another piece of news is that the FDA has recommended adding label precautions to flu drugs (Roche's Tamiflu and GlaxoSmithKline's Relenza) for causing serious neurological problems - hallucinations, convulsions - in children. Tamiflu is tied to 25 deaths - most of them reported in Japan - which include falling off high buildings and running/walking into the traffic. The FDA's action is limited - typically gentle to the manufacturer - because at this point it is "not certain" if the side effects result directly from the two drugs alone, or due to interference of some other factors.

What you can make out of this, comes in a form of a few simple rules:

#1 Don't give any medications to children unless you really have to

#2 If you do give medications to children, even over-the-counter kind, don't assume they're safe, either inherently or when combined with some other substance; even your doctor may not know the facts

#3 Do all you can and should for your child to stay healthy, and never need medications in the first place