October 11, 2007

WHOA. NYT: Makers Pull Infant Cold Medicines

How are new parents supposed to get more than four hours of sleep or travel to Asia with a newborn NOW??

The NY Times just reported that the makers of major infant cold medicines are pulling their products from the shelves rather than risk a formal ban by the FDA.

A safety review by the FDA recently recommended banning cough and cold medicines for kids under 6 years old. The pharma industry's own trade group had suggested warning labels and the elimination of the under-2 drugs.

Of the 1.5 kids/year who died from OTC cold medication since 1969, most were related to inadvertent overdoses, i.e., parents not following, understanding, or measuring the proper recommended doses.

I'd call these people idiots if I hadn't just bought a box of Children's Triaminic Thin Strips that turned out to be for 6-year-olds. It wasn't until we gave the kid one that we realized it was twice the dose of the previous box. But side by side comparison was all but useless; until I got online to look at the dosage levels, the only discernible difference in the packaging was the flavor: grape vs. bubble gum. Way to go, Novartis. [Though the kid did sleep spectacularly.]

Makers Pull Infant Cold Medicines

Previously, just last week: slo-mo infant cold band rolls on - slowly. Or, you know, quickly, depending.
08/07: FDA: stop giving cold medicine to kids under 2yo


They should just call them "herbal remedies" and then they won't have to deal with these troublesome problems like "dosage guidelines".

Here's our PediaCare story: Our kidlette is almost never sick, so the one time she started coughing and got congested, we called her doctor's office to ask what we should do. A nurse there told us to just give her PediaCare and she'd be fine - three to four times a day from the dropper. She turned into a complete zombie within a couple of hours - not eating at all and labored breathing. We called back, horrified. That time, we spoke to the pediatrician who told us that she advised against ever using PediaCare or anything of the sort. The nurse I spoke with denied ever telling us to use it, of course. Needless to say, that was the last time we ever used it, and we switched doctors.

[nice. this whole patchy situation illustrates the difference between actual scientific research and decades of mismatched anecdotes. And if the FDA is going to require full-scale clinical testing on these grandfathered-in medicines, I guess the drug co's just aren't going to make the effort/take the chance. -ed.]

My wife is a scientist who does research & development for a pharmaceutical company. She told me that there is a long list of products and chemicals that are approved by the FDA for use and consumption but that have never actually been tested. They've just been around for so long that they are "deemed safe". Really gives one a sense of security, doesn't it?

[indeed. it's that whole, We've been using it for decades, what could be wrong with it? idea. Which also applied to opium in the 19th c, and lead paint until 1978. Nice. -ed.]

I can't help but think that what this is really going to lead to is the same people who were overdosing their infants before trying to work out the dosages of the "kids"-caliber medicines, doing the math wrong, and overdosing their infants. (Of course, with an almost-2-year old in the house and another on the way, I fully intend to use the "kids" caliber medicines when necessary - I just plan on doing the math properly. :-> )

[I'm afraid you're right. People eyeballing it and improvising will probably cause more mixups. And it's not like baby colds are going to disappear, so parents'll be jonesing for *something*. -ed.]

So here's a thought, in Canada, they actually put the doseages by age and by weight ON THE PACKAGE for under two's, and isn't it amazing, parents do better with taking the info from the package then having to call their dr. or look it up on a website. Wouldn't that be quite a bit easier then pulling them off the market. The ingredients are the same in Canada, heck the packages are the same, except for the dosing directions in English & French, and with weight and age, so you can be sure you get it correct for your kid. As for the placebo effect, coughing child vs. not coughing child, hard to miss the difference. People have said the same placebo thing about painkillers after immunizations, but I'll take the medicated,not screaming kid with advil any day... I think the people who claim its a placebo just have extra good natured, or "not really very sick" kids to begin with.

[yeah, I was wondering what the Rest Of World is doing on this, or does Sweden just use a bit of vodka on the kid's gums, puts'em to sleep every time? true story, someone told me that on a plane once, when I said I hadn't doped the kid at all. -ed.]

The only problem is that they have also pulled the drugs from the Canadian market. That won't be good, as we will have 2 kids under 2 in just a few short weeks, coinciding nicely with our first cold and flu season with an older kid in school.This will not be fun.

We just did the exact same thing with the Thin Strips. Identical packaging for Children. Gave my 3 year old (almost 4) one. Then looked at the dosage and it was different from the box sitting right next to it. Both say Children's Triaminic Thin Strips - one for Cold with Stuffy Nose (1 strip) and one for Cough & Runny Nose (under 6 ask a doctor). Called the information line and they were completely useless. Told me to call our pediatrician, explain what we did and gave me the poison control hotline number for good measure. Why would they package what appears to essentially be the same product, and then have different dosages?

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