The FDA says oral phenylephrine, used in many over-the-counter cough and cold medicines, "is not effective as a nasal decongestant."
Summary
The FDA has proposed removing oral phenylephrine, a common ingredient in over-the-counter cold medicines like NyQuil and Sudafed, due to evidence that it is ineffective as a nasal decongestant.
The proposal follows a unanimous vote by FDA advisers last year, and recent studies showing less than 1% of the drug is absorbed into the bloodstream when taken orally.
The public comment period ends on May 7, after which the FDA may finalize the ban.
Good. Now do something about homeopathy. I'm so sick of having to explain to people that homeopathy is not medicine in any shape or form. It's not even a home remedy. And it sits right next to actual medicine so people might accidentally buy it unwittingly.
This was so infuriating during covid as it was hard to find children's cold medicine already and half the time you'd see a couple bottles of "Children's cold and flu" on the shelf, buy it, and get home before you notice "homeopathic" written in 3pt font along the bottom of the bottle. Shit's completely useless.
I've gotten into the habit of checking active ingredients after almost accidentally buying something homeopathic that was immediately adjacent the thing I actually meant to grab.
The problem is, unlike homeopathy, this drug was ineffective for what it was approved for while actually causing side effects. At least the water doesn't do anything.
I remember like a year or two ago when they officially announced these products are LESS effective than a placebo. How the hell is it taking so long to get them off the shelves?
I assume they submitted the results and stated they need to be removed, then reviewed the supreme courts measure that stated they only have power to make measures if Congress grants them privilege to do so (precidence, set in Julyish of 2022 with the EPA) making the specialized divisions of government created by Congress illegitimate unless Congress votes on the measure afterwards, making them just superficial recommendations for Congress to wait and see what their lobbyists think is okay.
Aka will drug companies pay enough to keep us lying to the public, vs maybe we will go by the recorded data.
Point being. what power did they have to remove them from the shelves. I assume they are launching these last ditch efforts before Biden leaves, and praying to get some support before they get chiseled away at.
Imagine where we would be if GM/Ford and such started forcing the R&D in 1975 instead of 2005, 2015 or whatever we call it now
By my understanding yes, pseudoephedrine was being used for meth so they put it behind the counter and the name brand "Sudafed" made a PE line that was this, phenylephrine, to stay over the counter.
It won't even take that - you can sell products that don't work (airborn, homeopathy, etc.), you just can't claim that it does. So they'll slap the standard "this product is not intended to treat, cure, or prevent any disease" disclaimer on it and people will continue to buy it.
I have been railing about how this shit doesn't work for what feels like forever.
The entire cold/cough aisle is essentially a scam. Pick up some generic diphenhydramine, APAP, ibuP, and some Pseduophedrine. It will cheap as dirt and do all the things that overpriced shit will do. Anything else that actually helps with a cold/cough is prescription only.
If you want some real solid advice: never buy the nasal spray that has phenylephrine. It may well be one of the most addictive substances man has ever made.
The pills do absolutely nothing. About once or twice a year I have to get the good stuff from the pharmacy, but I've refused to even buy the new stuff.
I can't help but feel like they could just put something in the regular Sudafed to make it not methy, but I took physics and not chemistry so idk.
What do I use then? I'm already addicted to Oxymetazoline (Afrin) and I need a way out. I've tried Propylhexedrine (Benzedrex) but it works for all of 30 seconds before I'm congested again. Even quitting cold turkey didn't work. I went an entire year without any nasal spray, suffered through the rebound congestion for over a month and was in the clear for awhile... Until the congestion came back. I don't know what to do.
I swear by this stuff and saline mist. You can use it as much as you want. It's the miracle nobody is willing to try.
The newer allergy medicine is good, but I think you have to take it for a couple of months before you really notice it. I like the generic Allegra from Costco.
And get some real Sudafed from the pharmacy. I do the generic 12 hour and split them in half (helps you from feeling queasy).
In the US, you can still get the stuff containing pseudoephedrine but you have to go to the pharmacy and ask for it and then show your ID. Out of curiosity, what's the process in Australia?
It's the same here. The Therapeutic Goods Administration, our equivalent to the FDA, generally follows along with FDA regulations (though I don't think that will continue from next year somehow).
It won't be pulled from the shelves - it'll just be getting some new fine-print.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
I like in the article how it says they'll get some time to reformulate, but if it doesn't work, they could just turn off the widget inserting it and bobs your uncle!
Interesting. I use phenylephrine pills (no other active ingredients) for nasal congestion every time I'm sick, and it has always worked very well for me
I do tend to be extra sensitive to most drugs though, so maybe that has something to do with it
Maybe for you it does, although you'd need to test with placebo to really know. It's amazing how much our minds can effect things if we expect things to change.
It could also be that your pills are a significantly higher dose. If 1% is absorbed orally, maybe that pill has 100x the dose required otherwise.
That’s probably the doxylamine succinate, which is an antihistamine and also relieves congestion.
As I understand it, studies have shown phenylephrine simply doesn’t do anything at the oral doses we get. It’s in there because pseudoephedrine got moved behind the counter because meth production can use it, but it’s essentially useless.
If what you’re really after is a decongestant, go to the counter and ask for Sudafed (or generic pseudoephedrine). They’ll probably ask for your ID because meth, but that shit works. I get the 12-hour kind, personally.
Keeping me awake would be a nice side effect if it meant I could take it whenever I realize my nose is fucked. With Nyquil I can only take it at night because it knocks me on my ass. It works great but I have to struggle through the first day I start having problems.
Sooo I see the thread is full of US people here and it's so strange. I don't have drug brand preferences. I go to my doctor, my doctor tells me what to take, I go to the pharmacy, they give it to me, and I take it as instructed.
I still usually call my doctor for OTC stuff, and if my doctor says I need it, insurance gets to pay for it. Going to the doctor usually saves me money. And if I schedule it during a workday, it's not my time going either but my employer's, if it even needs more than a phone consult.
From my understanding they don’t need to be FDA approved. At that point blame the store, not the FDA. I’m just glad they’re getting this done before they’re purged by the next administration
Yeah, you're correct, and in fact the Phenylephrine itself would still be allowed if they didn't claim it does something when it doesn't. All the alternative cures are labelled "homeopathic", "traditional medicine", or "herbal remedy". They don't say "Active Ingredients: Epson Salt 0.2% : decongestant, bees wax 1% anticoagulant" of some other shit.
My former boss (Canada) kept a bag of ephedrine bottles in our produce cooler. Dude was twitchy as fuck. Very bird/dinosaur-like.
He would take several per day and chase them with coffee and energy shots. Then he would complain intermittently about vomiting blood due to his ulcers.