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BLOG: October 2008

Keep the kids warm, or else...

Cold season is coming, and the FDA just can't decide to ban, or at least ask manufacturers for a voluntary recall of over-the-counter cough and cold medications for children under 6. Pediatricians are warning that these drugs are both ineffective and potentially dangerous in this age group. It is supported by the evidence. What is preventing the FDA from acting?

Maybe the fact that most of those 10%, or so, of all children that use these drugs at any given time are in this age group. It could hurt the sales, God forbid. And it (the FDA) already did narrow the market by issuing the warning against marketing these medications to children younger than 2. That came after the manufacturers voluntarily stopped selling cough and cold medications to this age group, this last fall, but it did act.

To tell the truth, the FDA didn't have much of a choice, after its own review of the available data showed that in the last four decades these freely available medications have killed 123 children. Most of them were younger than 2, which seems to be a good excuse for the FDA to limit its limited action to this age group.

Knowing how unorganized and unreliable is reporting system in general, it is all but certain that the actual number of deaths is significantly higher. Whatever the number could be, it appears that it isn't high enough for the FDA. Just how many children older than 2 has to die, in order to fill out its quota?

 The manufacturers - represented by The Consumer Healthcare Products Association - point out that most of these tragic cases result from accidental overdose administered by worried parents, ignorant of the deadly danger. So they are coming up with an educational campaign.

The problem is, campaign, no campaign, it still won't eliminate overdosing, and children will be dying from it.

The real point is that

these drugs are unnecessary.

Vast majority of colds clear naturally in a few days; all the doc usually does is recommend rest and plenty of fluids. And if the problem is something more serious, requiring medical intervention, these drugs can actually hurt a child by possibly delaying it.

For some reason, it seems awfully hard to get this simple fact across to both, the manufacturers and the FDA. They seem to be looking for excuses to drag their feet, avoid to do the obvious right thing, and keep the unnecessary, yet dangerous drugs on the shelves.

Keep your kids warm. Maybe your spouse won't read about this and, if the child catches cold, the next thing could be a bottle of off-the-shelf cold medication, to help the little one...