October 11, 2007

DT Currently Hoarding Infant Drops, Overdosing On Dosage Information

So the major drug makers--members of the Consumer Healthcare Products Association--are voluntarily pulling their over-the-counter infant cough & cold medicines from the market rather than be forced by the FDA to pull them [or to put decades-old, grandfathered-in drugs through infant-specific testing and approval]. The withdrawl, they say, is not because of safety issues with the medicines, but to prevent "potential misuse."

The recommended doses for kids under two which were in effect today are going to be NOT recommended tomorrow. Which'd be fine with me if we didn't have another under-2yo coming in a couple of months.

We had occasion to use several OTC infant drops with the kid, and to these parental eyes, they did the jobs they promised. So I went out and stocked up on them [after checking the expiration dates, of course.]

When they run out, I expect we'll do with the other kid what we always did with the kid: check the dosage appropriate to her age and weight, and then measure it out carefully and give it to her. For the moment, sites like The Medicine Cabinet at Ask Dr. Sears still list the concentration of active ingredients of major makers' pediatric medicines, and then list the recommended doses for kids of various 6-month age brackets. I'm going to save the info for the medicines we use for future reference.

There are vital pieces of info about which symptoms each medicine is for, what it does, and when and when not to use it, but as an example, here's the ingredients and dosage data on one withdrawn medicine, Robutussin DM Infant Drops:

Ingredients: per 5 ml:

* Dextromethorphan 10mg (Cough Suppressant)
* Guaifenesin 200mg (Expectorant)

...

DOSING CHART

Use supplied calibrated oral syringe.

less than 6 months (<14lbs): Not recommended
6-11 months (14-17lbs): 1.25 ml (¼ tsp) every 6-8 hours
12-23 months (18-23lbs): 2.5 ml (½ tsp) every 6-8 hours
2-6 years (24-47lbs): 2.5 ml (½ tsp) every 4 hours
over 6 years: Not recommended, use syrup

So if you're confident in your math ability and would like to be able to replicate the dosages of medicine you've used in the past, maybe you should grab the info while you can.


The Medicine Cabinet: Complete List of Medications A to Z [askdrsears.com]
See the CHPA announcement and the list of medicines being withdrawn [chpa-info.org]
Previously: NYT: Makers pull infant cold medicines

12 Comments

I realize you feel that something useful has been taken away from you, but even in adults, both "active ingredients" are widely suspected of being no more effective than placebo. Knowing there's at least some risk of adverse effects, why bother?

Personally, I have great faith in the restorative powers of a little medicinal bourbon. Why not measure out a pony of that? Probably help the kid sleep just as well...

g

[see, that makes no sense to me. the risk associated with these medicines is that I can't count to 2.5 ml. If that's a real risk the kid faces around me, she's gonna be doomed in a hundred worse ways already. As for the placebo thing, can you have a vicarious placebo? Can I just imagine that a kid sleeps or stops coughing? And the liquor, well, we have religious issues with that, so for some folks, we're already totally off the other end of the rationality scale there. If this ban sticks, I'm sure there'll be a resurgence of good old fashioned remedies like gripe water and elixirs, all of which will have a very non-placebo-like amount of alcohol mixed in. Stay tuned -ed.]

Perhaps I can help by restating these concepts in issues familiar to you:

"the risk associated with these [1 million recalled cribs] is that I can't [assemble them correctly]. If that's a real risk the kid faces around me, she's gonna be doomed in a hundred worse ways already."

and regarding placebo effect:

"Can I just imagine that a kid [reaches developmental milestones sooner after using BabyPlus Prenatal Education]?"

And believe it or not, parental placebo effect is real and documented, but you can call it vicarious, if you like.

g

P.S. Before resorting to any remedies from Three-toed Zeke's Backwoods Apothecary and Bait Shop, understand that what's being pulled here is more about "labeling" (in the legal/pharmaceutical sense) than product. You'll find the same products in the same concentrations on the shelf... just no "infant" on the box.

[what's up with the snarkback? do I sound like that big a dick about this, too? I assess the risk for my kid in a realistic and empirical way, measure twice and dose once, avoid medications that don't match the specific symptoms, and when I see I don't screw up and my kid doesn't have adverse reactions, then yes. At that point, I don't really care what some pharma trade group is doing to try and cover their asses, or what segment of the market they're willing to forgo in an attempt to avoid further government restrictions.

I'm under no illusions that this is a labeling and picture-on-the-box change for the most part. It's why I posted this in the first place, to document the changes that are about to happen in the dosage recommendations. (or in Sears' dosage recs, to be exact.) It's also the point I'm making that this is what I'm doing because of how I'm thinking it through. It's most definitely NOT me telling anyone else what they *should* do. A kid whose parents use just ye random blogger as a medical decisionmaker is in trouble and could probably use a stiff drink. -ed.]

Well, yeah, you can have a vicarious placebo. When they tested, placebo scored really very well. Here's one study where placebo outscored diphenhydramine.

Plus, given that we all can count to 2.5 ml, exactly how much more trouble is it to count to 1.25 ml twice? Because they're not pulling single drugs, just combos.

[but wait, the parents in both groups stayed equally unhappy? (4 out of 10) Also, I'm alarmed that 71% of parents give their kids drugs to go to sleep. But point taken. -ed.]

So, yeah, I'm going to join the "vicarious placebo" pile-on. There very certainly is such a thing. It's also known as observer bias, and it's why good studies are done with a *double* blind -- neither the experimenters nor the subjects know who's getting what until the data is recorded and analyzed.

[i'm not discounting the existence or importance of an actual placebo effect, which is not the same as "no effect." If a parent feels better for dosing his kid, and thus is less stressed and thus cares for the kid better, I'll take a case of placebo drops, please. But I don't think the issue with these medicines is placebo effect, so much as questions of efficacy at all. I just listened to the NYT reporter on the sidebar interview mp3, and he emphasized that these drugs are trapped by a shift in the medical paradigm; "no one really believes" anymore (in the medical community, that is) that these adult medicines work the same way in kids, but that they don't know how they work, or what the effect actually is. If consumers don't share that same perspective, then the whole thing is a giant, ignorance-based placebo effect. -ed.]

Do you think this move will result in thoughtless parents trying to dose their kid with adult cold medicine, and thus overdosing even more?

["just give him half a teaspoon." If some parents feel comfortable deciding their own baby-sized dose of alcohol, I expect some will feel comfortable guessing with whatever medicine is on hand. most'll use children's medicine, tho. -ed.]

I just keep my kids in a plastic bubble. Solves all my worries (except the one about the cat clawing the bubble and popping it).

[also the plastic, which has Bisphenol-A contamination. -ed.]

Snarky? Yeah, I guess so... but I couldn't help myself. I found the juxtaposition of your apparent stances on these two product recalls (cribs and drugs) WAY too amusing. Do you disagree that there's a little logical disconnect there? (Seriously, it's a little funny...right?)

On the one hand, the cribs were really only dangerous if you didn't read the instructions carefully and assembled them incorrectly. On the other hand, the drugs are only dangerous if you don't read the instructions carefully and administer them incorrectly.

3 kids died in the cribs, whereas I see numbers in the 50-60 range from the cough medicines, most definitely 3 in the last few years. While I agree that a thoughtful, intelligent parent can safely measure and administer these drugs, the mounting information that the payoff is either small or nonexistent, coupled with the reality of a thousand or so kids heading to the ER every year because of parental confusion of dosing and combination products [CDC], leads me to believe this is a smart move.

g

no, I see your point, and I didn't mean to be such a dick back. But I do see differences.

The crib was designed and sold in a way that's makes the deadly mistake possible, maybe even likely, I don't know. Were awful drawings or directions to blame? What's the comparable medicine flaw, unmarked syringes? Identical bottles? apples-to-oranges labels? Since recalls don't work anyway, those cribs will still be out there posing a risk.

BUT the risk is zero if you don't have the crib, 1/300,000 if you have the crib, maybe 1/100,000 if the crib's assembled incorrectly. But what kid doesn't get colds? And what parents don't use medicine?

Of 8mm under 2-yos in the country, 1-2 will die from parental error, OD, combination or some unexpected, unknown reaction to OTC medicine.

If withdrawing the meds would actually stop parents from dosing their kids with *something*, great. Instead, though, they'll turn to improvising, either with child medicines, adult meds, or maybe that timeless cure-all, bourbon [which does what, again, for cough or sinus problems?]. This could turn out to be a whole, SIDS-like, sleep-on-your-back campaign that takes years to drill into peoples' heads, but the data just isn't there for me yet.

As I'm probably demonstrating all too clearly, every parent thinks he's above average and knows what he's doing. I don't expect to turn out to be one of the thousand idiots rushing his kid to have her stomach pumped, but then who does? At least I'm trying to find actual Dr-recommended dosages before they go down the memory hole.

We have been fortunate in as much as neither of our kids have been sick with colds very frequently so the issue has rarely come up in our home. That said, we have discussed it. Our pediatrician recommends nothing more than Tylenol and ibuprofen until the age of five or six. In addition, our own research supports our pediatrician's recommendations. But the clincher for me is my wife. She's a clinical pharmacist and as a result rather well-educated in these things and I tend to defer to her (even if I do tell her the "Dr." in front of her name is purely decorative). She just doesn't see any benefit in the meds in any of the research and the potential detriment is too great.

I am not impugning any parent's decision regarding their children's health but I sometimes think that dosing kids is done as much for the benefit of moms and dads as for the children. When our kids get sick we can't stand not doing anything to make them better. We can hold them and suck all the snot they produce but in the end we tend to fell rather impotent without a "cure" in the medicine cabinet. Our peace of mind shouldn't be underestimated, however that may be the only effect of these meds and that really isn't why we should medicate others, is it?

I too have been known to resort to medications for a (half-way even) decent night's sleep, I must say that I stick with the decongestant only or pain/fever only meds (sometimes in combination) never a cough supressant for two reasons: 1) chances are if the kid is coughing when s/he is lying down its because the runny nose is irritating the throat and if it isn't from the sinuses then the chances are that the stuff in the lungs needs to come out it should or you run the risk of a cough turning into something worse. So I give decongestants (appropriate to weight) elevate the head of the crib/bed and hope for the best. But that's just my experience (and based on advice from pediatricians). Yes it drives me crazy to listen to my kid coughing in the night, but I must say its rare that it keeps the kid awake...just the parent. so I guess I'm lucky that the recall won't affect my ability to medicate my kids.

[otoh, maybe it'll be a bonanza for parental sleep medication. -ed.]

My kids are 15 and 13. I used to give a cough syrup to my older boy when he was very little (less than two years old), but I realized something: the more I gave it to him the more often and more sever he get sick. So I stopped, and never gave it to either of my kids again. So what if they cough and sneeze and cannot sleep for a few days!! that will not kill them, it can just make them stronger!!!
In fact since, I stopped giving those poisons to my son he was barly ever sick. My younger one has never had any cold medicine (belive it or not), and I don't even remember when was the last time he had to skip school due to cold.

[thanks, I think the server chopped out the part of your story between medicine and "these poisons". I've gotta go pick up the kid from her Kid Nation prep class, brb. -ed.]

This may seem stupid and off-the-point, but we've had some really good experiences with this crappy $10 Vicks hot mist humidifier (available at every Target and Walgreens) into which you dump $7 bottles of Vicks menthol-brew. On the one hand, it definitely seems to be a complete grift (when our 18 month old had the croup we were going through $10 worth of menthol brew a day) but on the other hand, it really helped him breathe. When it was really, really bad we'd pull the car-seat out of the car and have him sleep in there. Coupled with infant-motrin and Vicks baby-menthol-cough goo rubbed on the handle-end of his nuk it satisfied our need to help, our pediatrician's instructions not to give him anything stronger than infant-motrin, and his need to sleep and recover... Oh well, just a suggestion for those seeking another option.

[thanks, it couples well with the important info above that a lot of times, a kid's nighttime coughing is due to congestion+lying down, and that there are other non-medicating solutions. My wife has since pointed out that I sound like a drug fiend, when in fact, she feels we take great care and don't medicate the kid with stuff she doesn't need or at times when she doesn't need it. The 71% of parents who supposedly drug their kids to get them to sleep, I'm looking at you. -ed.]

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