Yesterday, the U.S. Food and Drug Administration issued a strong recommendation to citizens of this country: Stop drinking anti-itch gels. They're meant to go on your skin. People who swallow them - and the FDA has been tallying up a series of cases - tend to suffer from dizziness, hallucinations or fall unconscious.
At that point, they probably aren't too bothered by itching, of course. But I have to think there's an easier way.
Most of those who mistakenly gulped down a few squirts of gel were consumers of Benadryl Itch-Stopping Gel. They apparently assumed this was just another version of the popular drinkable anti-histamine formula. And they've apparently been assuming for a few years, since the FDA issued a similar warning in 2008 regarding seven cases of gel-drinking sickness.
Now, to me, the word "gel" is kind of a giveaway. But, for those who may be thinking"drinkable" gel, there are also the words "Topical Analgesic". This should also be a giveaway, but you could argue that the letters are kind of small, that they don't offer the in-your-face, don't-drink-this kind of signage that appears to be needed at this point.
Of course, it may be that some people get the topical point. If I look up "topical" in an on-line dictionary first definition I get has to do with current affairs, matters of local interest. It takes a while to get to the medical definition of "applied externally." Analgesic, of course, refers to pain relief. Maybe, a few gel-drinkers read it as a sign of a trendy pain killer. Or - here's my best guess - maybe they don't read them at all.
And I'd bet the blog that few people think through to other two words on the label - Diphenhydramine Hydrochloride - either. But they should, on the basic principle of know what you're swallowing - gel or no. Diphenhydramine is the active ingredient in all forms of Benadryl and many other antihistamine formulas.
Scientists have known since the 1940s that it could interfere with the body's immune reaction to irritants - from pollen to insect bites - by blocking the action of histamines, compounds which help regulate the inflammatory response, everything from tissue swelling to running eyes. As always, changing body chemistry with one intention tends to bring on other, unplanned changes. Antihistamines famously (and to some people, usefully) cause drowsiness but they've also been linked to everything from vertigo to heart palpitations, according to how an individual responds.
The problem with slugging down the gel, according to the FDA, is that instead of getting the carefully regulated dose in the liquid medicine, gel drinkers seem to end up swallowing too much of the active ingredient and showing the symptoms of anti-histamine overdoses.
But equally dangerous, if not more so, unlike the oral medication, the skin gel contains camphor, an organic compound which is notably poisonous in high doses. In fact, although the FDA's warning doesn't focus on camphor, the non-profit Institute for Safe Medical Practices emphasizes it as the more dangerous ingredient. In fact, dizziness and unconsciousness are classic symptoms of camphor poisoning.
Apparently, though, the FDA has realized that "topical" labeling is just not going to work in the case of your average gel drinker. So the agency has persuaded the manufacturer, Johnson & Johnson, to stick not one but two new labels, one on the bottle and one on the cap, both saying "For Skin Use Only."
And if that doesn't work, the company has also agreed to research "factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel." I'd like to encourage Johnson & Johnson to make those results. I'm sure they would be of great topical interest.
I think what they should do is put it in a tube instead of a bottle.
Good point. The bottle does add to its "drinkable" look.
I agree that the bottle is probably a significant factor. A lot of people probably don't read farther than "Benadryl" before squirting a slug into their mouth. I tend to stick with tablets when recommending antihistamines for pets-less chance of confusion over dose-but this is another good reason I hadn't thought of before.
Has literacy been considered? A non-trivial number of US adults are not able to read English well enough to comprehend those label warnings and instructions. This makes a confusing container that much more dangerous.
That's a really smart point, Ellen. I haven't seen any graphics on these bottles that would warn non-English readers. But there should be.
on a slightly misanthropic note: if they were too stupid to read the label to find out how much to drink, why should anyone be surprised that they were too stupid to realize it wasn't supposed to be drunk in the first place?
sigh. you've got a very reasonable point.
This is scary. I certainly never take any medicine until I have actually read the instructions. Though one would think that a gel for itching would be obviously for external use. I might also point out that the cap on this bottle is very obviously one for squeezing out the gel.
People are mentioning that the possibility that the people drinking this medicine can't read English. If that is the case then how did they know the bottle was for itches in the first place? Please don't tell me they are going to the section in the grocery store dedicated to over-the-counter medicines and picking up random product. Even if they are going by the brand name, that still covers quite a few different products and no one can possibly not know that the same brand name can cover a wide variety of products.
Maybe "gel" is a giveaway or at least a help cue to some generations, but less so since all the sales and high profile advertising of various "sports" goos. Probably the concept was well defined when we had only Jello and has been losing shape since shampoo.
how about just calling it "skin cream" or "anti-itch lotion" and definitely change the bottle to a tube.
pretty sure that would stop about 95% of the problems.
Agreed. And an interesting question is why they didn't do that a decade ago when these problems started popping.
I have to wonder if the camphor is really the active ingredient that's responsible for stopping the itching, rather than the diphenhydramine hydrochloride in this topical application. Camphor is a major ingredient (usually around 10%) in Chinese medicated oils such as "Axe Brand". I love the stuff for mosquito bites.
Agree with what other people said on packaging, a squeezy tube would be a lot better. There isn't anything you ingest that comes in a squeezy tube, is there?
There are gel candies for kids that come in squeezy tubes. And anchovy paste for grown ups. And frostings in decorate colors. But I think you're right that we usually don't think of medications in tubes as something to swallow. As for camphor, definitely, fascinating compound and I've put it on my list for a future blog. Thanks for writing!
It seems to me that packaging the gels in a bottle like that is a response to the perception that stuff in tubes is gross and messy.
You can already get several brands and kinds of anti-itch gels (including Benadryl's anti-itch gel for kids)in a tube, and the website notes that the bottles now have a new label with more warnings.
This story reminds me of the contraceptive jelly on toast urban legend: http://www.snopes.com/pregnant/jelly.asp -- interesting though that the usually sensible Barbara Mikkelson comments: "But a woman suing a pharmacy because she didn't read the instructions on an over-the-counter contraceptive and mistook it for a food product? No way."
That urban legend originated in a [probably fabricated] Weekly World News item, but there was in fact a lawsuit over the labeling on contraceptive jelly in 1982, and (as is usual with a good urban legend) there is a little bit of overlap in the two.