Tuesday, April 08, 2008

Cold Data on the Cold Meds


So you might have heard cold and cough meds send about 7,000 kids to the ER. If you're like me, you had some questions upon hearing this number. Where did it come from? How old were these kids? Did they take the correct dose? Did they help themselves to those candy-colored, fruit scented bottles?

But then I read an article in this month's Pediatrics journal. Researchers Melissa Schaefer and her colleagues examined emergency room visits in 63 U.S. hospitals for kids up to age 11- specifically, visits doctors directly attributed to the use of cold meds (a term I'll use for both the cold and cough products). During the course of the study that amounted to 301 cases. Thank you, Melissa et al. - I just love having some numbers to put this issue into perspective. A good chart is almost as good as a box of chocolates.

Here're the number of visits by age group:

< age 2: 66
age 2-5: 199
age 6-11: 36

total: 301

Here's the breakdown on how the kids received the medicine (% of cold-med trips to the ER):

Unsupervised Ingestion (kids self-ingested): 66%
Supervised with Error (adults gave wrong dosage): 8%
Supervised without Error (adults gave correct dosage): 26%

A few curious facts. Two thirds of the ER visits resulted from kids taking the meds on their own - the overwhelming majority, preschoolers (155). Among preschooler, most ER visits came from self-ingestion (78%) than either supervised, either ingested with errors (8%) or without errors (18%).

Yes, but, do the drugs pose dangers?

Well, interesting question. Considering all the self-administerings, the not-so-child-proof packaging makes them dangerous, especially to the preschoolers. And then there's the dosing errors - that accounted for 18% of ER visits by the under 2 crowd. Not surprising since there is no dosage info on the packages for this age group. Go figure.

Okay, but are the drugs themselves dangerous?

Look at the kids who got correct doses but had reactions that sent them to the ER. Among ER visits attributed to all other medications - those at correct dosages accounted for 51% - twice as much as for the cold meds at correct dosages (26%). So compared to other drugs, the cold meds result in a lower rate of ER visits. I assume the other drugs include prescription and other OTC drugs. I would have liked to have the breakdown on types of drugs, to see a comparison between cold meds, and say, tylenol. Or between prescriptions and OTC. But that's another study.

And what about the official concern that these drug pose special dangers for kids under 2? Take the number of ER visits for reactions from correct doses:

< age 2: 21
age 2-5: 36
age 6-11: 20

The same amount for the under 2 and over 6 groups. So why has the FDA called for the ban for the younger than 2 crowd? They look just as harmful for the older crowd. Or just as safe. Either way - the numbers are not significantly different. Is there any reason to believe one crowd uses more of these drugs? It may be that the older kids get more of these meds, simply because many parents might be reluctant to give them to their toddlers and infants. If that's so then the risk might be significantly lower for the older kids. We know all drugs carry risks. And to really estimate risk we need to know how many doses are adminstered each year. Now we do have some estimates. As I wrote in an earlier post, over 40 million bottles of children's cough and cold medicine (approx. 8 million were drops for infants) were sold in just over over 6 months in 2007. That's around 80 million bottles a year total, about 16 million for infants (these marketed for the under 2 group) and 64 million for the older kids - and I assume these were for kids two and older. Conservatively, let's say there were 6o million doses given last year. And we can estimate reactions from appropriate doses accounted (26% of all cold med ER visits). So that's 1,800 annual reactions out of 60 million doses - that's .003% chance of an ER visit for giving your child cold medicine.

Now I'm sure there is more reason behind the FDA decision, a perusal of case histories that the general public cannot access. A lot of it also has to do with issues of efficacy. But don't you wish someone in the know would explain the ban in light of these figures???

Read the study at http://www.pediatrics.org/.

BTW, I've pondered cold meds on 2 earlier posts.

Schaefer, M.K., Shehab, N., Cohen, A.L., Budnitz, D.S. (2008). Adverse Events From Cough and Cold Medications in Children. PEDIATRICS, 121(4), 783-787. DOI: 10.1542/peds.2007-3638


jen said...

i wondered who those 7,000 kids were too. i don't really give the cold medicines to my younger kids because i don't think they do much.

p.m. said...

The numbers are interesting. I would like more information on the efficacy of these drugs.