I don’t have access to the bottles right now to compare, so I was wondering if anyone else was familiar with this product change.
*** note - not asking for medical advice, just wondering if this is an actual formulation change or slick marketing.
We just ran out of Robitussin DM at the house, so I dropped by the store to pick up some more this morning on my way into work. To my surprise, Robitussin is now labeled as “Adult” with dosing instructions that specify not to give to children under 12 years old. I am positive that the old bottle at home had dosing intructions for children 6-12 years old. Otherwise it would have given me pause to administer it to my little rainydrops. FTR I had been advised it was safe for the rainydrops by our pharmacist.
So what’s up? I went to Robitussin’s web page to see if some horrible side effects had come to light when using the product on young’uns, but there is nothing there. So has the formulation changed (I can’t check that myself right now), or has marketing changed, or what?
The FDA changed the labeling on OTC Cough and Cold products awhile back to remove dosing for children under 6 years old, and put “Ask your doctor” on there. The reason for this is that there were many parents who were overdosing their children on OTC medications without realizing it. Plus, there is debate on if dextromethorphan is actually effective in children.
I’m not aware of any change in Robitussin DM’s formula lately, as far as I know it is still 100mg of guaifenesin and 10mg of dextromethorphan per 5 mL.
Wasn’t there a big brouhaha a while back about giving children products containing pseudoephedrine? IIRC, they reformulated a bunch of things after that.
A few years back, the FDA reviewed the evidence for cough and cold medication in children, and found that while there are several deaths (and a bunch of other adverse effects) each year due to dextromethorphan use (the DM in Robitussen DM), there wasn’t really any good data to show that it was helpful. At the time, I worked for Wyeth, then the maker of Robitussen, and I actually was one of the people who read through all the original studies they did from the late fifties through the eighties; I don’t know if any were published, as I was seeing internal files. They’re truly terrible, enough that you can’t draw any conclusions whatsoever from them. A typical example might be that the medication was given to any residents of an orphanage for Negro children (their language, not mine) with coughs, with a nurse assessing if they got better faster. No control group (all the coughers got it), and certainly no consent from anyone.
IIRC (it’s been a while), the FDA came out very strongly against the use of cough/cold products in children under two, and recommended against their being used in under-sixes. The drug companies offered to withdraw all products for those under six. I don’t think there were any reformulations, just changes in dosing guidelines.
The pseudoephedrine thing was more about hysteria about people being able to somehow cook it into crystal meth. Some localities started to make it behind-the-counter, that you needed to go through a pharmacist and sign a registry before being allowed to buy a limited amount of medications containing it. The drug companies got scared that this would limit profits, so they reformulated with a different compound, phenylephrine, which doesn’t really do much as a decongestant but which can’t be turned into crystal meth, and which can be sold anywhere.
Yeah, the FDA, in its infinite wisdom, decided that rather than providing people with any sort of useful guidelines, people with kids under 6 should just suck it up and deal with it, especially if your kid comes down with a nighttime cough that keeps him and everyone else awake in the house…loong past the time when your doc has stopped answering the phones and the pharmacists have gone home.
Dextromethorphan is a lousy drug. There’s minimal to no evidence that it is effective, and plenty of evidence that it has significant side-effects and that it’s abusable and regularly abused. It has a PCP-like effect in higher doses. It works on the same receptors that PCP does.
I don’t recommend it for infants, kids, or adults.
Oh, man, I’d forgotten until I read QtM’s post, hearing stories in college from some dumbass friends of mine who’d down a bottle or two of Tussin, and then - if one can keep from horking it all up - apparently trip like nobody’s business. I was never around them when they did it (that I know of) but they had some … stories, that’s for sure.
Not really. Benzonatate is often touted for this purpose, but the best designed studies out there tend to show it’s no more effective than placebo.
Opiates do work, however.
I generally only prescribe those for severe coughs where the person is rattling themselves apart. Remember, the cough is usually there for a reason, to protect and clear the lungs. Suppressing this function can lead to complications, such as pneumonias developing on top of run of the mill colds and bronchitises.
In addict circles, it’s generally regarded as a shy drug with a shy high. Popular with the “any buzz is better than no buzz” crowd.
Occasional ‘spiritual voyagers’ talk about reaching the ‘third plateau’ with it. They never seem to come back more well-adjusted from these trips, though.
That wasn’t/isn’t hysteria. Meth (be it crystal or otherwise) is no joke. Meth gets people killed through use, abuse, violence, and economics via competitive trafficking. And it really is synthesized, in part, from cough medications. As to your assertion that Robitussen never contained any, I’ll take your word for it; there’s also the magic of Robi-dosing, where idiot teenagers, unable to score “real” drugs would chug bottles of the shit for the psychotropic effects of the DMT in it.
ETA: I should have read the subsequent comments on DMT. Also, I’m once again pleased by QtM’s insight into this.
Yes, you can synthesize crystal meth (whose terrible impact I do not want to minimize) from pseudoephedrine, but the vast majority of it is made on an industrial scale by gangs who import it, rather than being home-brewed.
It does not contain the ingredient you mention. I applaud agencies stepping in to try to protect kids, but this one was just plain dumb. I’ll look forward to the studies that prove it has saved lives.
You’ve said this before, and I respect your knowledge, but I certainly feel like it helps me. It could well be a psychosomatic response. I also think I notice a slight mood enhancement from it. FTR, I am using the recommended doses though I may not have been as careful when I was younger. I used to live on DayQuil when I got sick, and it really helped me to get through the day. I try to avoid acetaminophen products for colds now. Also, since they dropped psuedophed from the ingredient list, I pretty much had to start taking each drug individually when I get sick.
I actually find that Guaifenesin is the best cough suppressant–when it’s supposed to be an expectorant. Opiates don’t really stop the coughing–they just make them hurt a whole lot less.
Guaifenesin, rather than making me cough more, makes the coughs themselves more effective–I cough twice and I’m clear, and thus don’t need to cough for a while. My hydrocodone only stopped coughing in the sense that it made it hurt less, and thus you don’t feel like you need to cough any more.
BTW. what QtM doesn’t seem to be getting is that, by leaving out the instructions, most people will wing it instead. That leads to a much higher abuse potential. It’s not really relevant whether the medicine really works, when it comes to withholding information.
Well your response to my post left me with the feeling that you didn’t understand my complaint, you just thought Dextro-whatever was a bad drug and should be withdrawn.