January 17, 2008

FDA Makes It Official: Stop With The Cold Medicine For Kids Under 2yo

Well, don't say you didn't know it was coming. The FDA issued an official public health announcement today stating that over-the-counter cold medicines and decongestants should not be given to kids under 2 years old. The drugs can cause "serious and potentially life-threatening side effects" that, though "rare," include "death, convulsions, rapid heart rates, and decreased levels of consciousness."

Though it's in the AP report, the CDC's finding that 1,500 babies/year ended up in the ER because of cold medicine complications was not mentioned in the FDA report. Neither was the fact that the vast majority of those cases involved overdoses caused by the confusing multi-symptom drugs the manufacturers prefer, or by improper dosage measurements.

Anyway, hoard if you must, and if you mustn't, use honey. Then sit back and watch the tally of accidental overdose cases roll in as desperate parents totally wing it with grownup/childrens' medicine.

FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products [fda.gov]
FDA: Cold medicines too risky for tots [ap/yahoo via dt reader darren]

Previously, beginning here: FDA Panel votes to ban cold meds for kids 0-6. 6 years.

4 Comments

These have been gone from Canadian shelves for about 6 months now (possibly more). I don't think they are even selling baby tylenol any more. In fact, up here the recommendation is nothing for under kids 6, unless prescribed by a physician.

My sister is one of those parents who helped push through these recommendations. She was giving her son cough meds and baby tylenol for a couple of weeks and was complaining that the meds weren't working because her son was falling asleep, becoming disoriented, falling down and laying around in a daze. Turns out she was seriously overdosing him!

I've always been told, however, that the cough and cold meds had little to no effect on children anyway. Tylenol has some use for reducing a fever, but a not too high fever is useful for getting over an infection. I suppose, if your child had a fever so high that it required intervention, you'd want to be supervised by a physician anyway.

They should just bottle a bunch of different kinds of placebo meds so we parents can feel like we're actually doing something when the little ones get sick.

[Canada: it's just like America, without the 6-mo bureaucratic delays! -ed.]

My mom would never give me over the counter medicine as a kid. She would always tell me if I was sick enough for medicine then I needed to see a doctor. When my husband and I first met he couldn't get over that I didn't have a single OTC med at my place, not even Asprin. We've gone round and round about giving it to our own kids, but, who's the crazy hippie now?! (Probably still me.)

Those planning on hoarding the medicines beware... now that they've been officially banned if *God forbid* something were to happen to your child after you give them one of these meds, well you've been warned and rewarned. They are doing the smart thing, saving their butts. No parent can "accidentally" overdose their child again and blame it on the company (even if the directions on the bottle are a bit unclear). And the same goes for attempting to give smaller doses of medicines not really meant for kiddos... you're on your own. If something goes wrong it's all on you.

Throw out the bottles of medicine you have in your homes and use the old fashioned remedies. If you feel your child is sick enough to REALLY need a medicine for their cough or illness then take them to the doctor because there will still be prescriptions available.

[i don't know what this means, Rachel. The labels never said a dose for under-2yo anyway, the pharmas pawned it off to doctors, who had no research-grounded basis for their recommendations, just years of anecdotal experience and body weight-based dosage calculations. It's always a parent's responsibility; if this changes anything, maybe it'll be the people who have blindly assumed that "OTC=safe in any dose or circumstance, or else why would they let it be sold, right?" Some meds are now being demonstrated NOT to work with kids, flatout. And some "old-fashioned" remedies are being shown to actually work. Parents just need to think, which should surprise no one. But alas, I'm sure it'll come as a shock to some folks. -ed.]

Ahh... I thought they were still including the "6 and under crowd" now I see it's only the "2 and under." However, I know many many parents who once their children reach the weights on the bottle (regardless of age) will dose them up with those instructions.

Basically, I stick with my original post though... anyone with infants intending to hoard these cold medicines for the coming months should just throw them out.

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