Context for readers from countries where this isn't an issue, or anyone who hasn't followed decongestant news: one of the most effective decongestants is called pseudoephedrine.
In the past this was easily available, with the most popular brand being Sudafed. My parents always told me that one should take Sudafed when flying after having had a cold, in order to avoid severe ear pain from the pressure changes, but people would also obviously take it when not flying, just in order to reduce the discomfort of the congestion itself.
Pseudoephedrine is very effective. It is also used to synthesize the somewhat related illegal drug methamphetamine ("meth"). Historically, meth manufacturers would hire people to buy large amounts of pseudoephedrine pills at pharmacies and supermarkets, then grind them up and synthesize meth from them.
In order to deter this, authorities in the U.S. restricted the availability of pseudoephedrine, while not making it prescription-only, by limiting the amount that people could buy, and requiring buyers to show ID and be put on a registry (which law enforcement could use in investigations). I think this is the only drug that is treated this way. Some people stopped buying pseudoephedrine entirely, either because they were offended by these rules or because they were afraid that they could wrongly be implicated in meth investigations if they appeared to buy it too often.
The pharmaceutical industry produced an alternative called phenylephrine, the substance that this proceeding relates to. Most manufacturers of pseudoephedrine-based drugs, including Sudafed, formulated alternative decongestants using phenylephrine. There are no legal restrictions on phenylephrine drugs; one can buy them anonymously and in any quantity. Customers have complained for years that these are much less effective than the original formulations.
A couple of years ago this regulatory authority started looking into the question of whether phenylephrine is actually completely useless as a decongestant (rather than just much worse than pseudoephedrine). Their preliminary review of studies suggested that it is probably, in fact, useless. This proceeding is now proposing to ban it on the grounds that it's ineffective and so people should not be encouraged to buy and use it as a medicine for purposes for which it doesn't actually work.
(There doesn't seem to be much corresponding initiative to remove or reduce the restrictions on pseudoephedrine.)
So at least here in Germany, we pretty much all use nasal spray with xylometazoline, and it's very effective as it also binds to adrenergic receptors. It does not seem to be available in the US, and at least from a cursory search I cannot find out why...?
EDIT: After looking a bit more, the simple answer seems to be that it's not FDA approved for nasal congestion, and since there's not much money to be made, there's simply no incentive to go through the costly approval process..
They have oxymetazoline but I think the problem with this class of decongestants is that it is ineffective and dependency is basically guaranteed if used for more than a couple of days
Oxymetazoline is different from Xylometazoline, although it was derived from it. Xylometazoline is pretty harmless for adults when not used over extended periods (it is advised to not use it longer than 6 days, but that will cover your typical cold). It is true that if you take it regularly over extended periods, you will have a rebound effect and your nose will get congested when not taking it, so in that way, you develop a "physical dependency", but that's obviously much more harmless than other medication dependencies. Getting off a Xylometazoline dependence means that you'll have to deal with a congested nose for a few weeks...
I don't see from your comment how the risk from congested nose for a few weeks deems it "harmless" for you. Two fully congested nostrils is hell for one night alone, imagine a few weeks of that. A few weeks of terrible sleep, if any. It's torture.
It can also cause permanently enlarged turbinates with chronic use.
I said it's more harmless than other medication dependencies, like getting hooked on pain medication or benzos. Even here in tightly regulated Germany, Xylometazoline can be bought without a prescription. It is very effective and, compared to other drugs, pretty harmless.
Look, there are always extreme cases. Just look up how many people need a liver transplant or even die each year from misusing paracetamol. So should we make it a prescription drug? Maybe, I don't know, it's always a trade-off.
Worse, the symptoms gets worse after you stop using it, see rhinitis medicamentosa.
Many people have used decongestants so much they cannot quit them or will have to suffer weeks of nasal congestion. I risked going through that; later I swore I will never touch one ever again.
I’ve wondered this also. As an American who lived in Germany and found this while living there, I can attest that it’s quite effective for me. There are other quite useful and safe drugs that are not available in the US.
There are nasal sprays in the US - and yes they are more targeted and better in general than pills. But Americans love their pills ... almost as much as Germans love their homeopathic remedies :-)
Good summary. To add to what you've said, Sudafed (as an example brand name) opens your eustachian tubes which are passages from your inner ear to your throat. If you think you might be getting an ear infection, Sudafed increases draining and potentially helps prevent a worse infection. As mentioned, it helps air equalize to the atmosphere via these tubes. If you make a yawning motion now and hear your ears crackle, that's the air moving through your eustachian tubes. You'll notice that crackling decrease when an ear infection may be imminent. I tried the useless alternative and discovered on my own that it was, indeed, useless. And it was quite expensive, with great marketing on the box.
I read this and was puzzled, until I realized that you are talking about the pills. The nasal spray is effective, although probably not more effective than a saline solution.
> although probably not more effective than a saline solution
I guess saline is a baseline against which effectiveness should be measured here, especially since nasal sprays are usually saline plus something. (I guess? Not sure about Sudafed specifically.)
I'd argue that saline should be the panacea here. I doubt very many people do at-home saline rinses with filtered, sterilized water and a simple mixture of salt and baking soda.
Do people really want to spray PFAS water directly into their mucus lining?
I bought an Arm and Hammer Saline spray out of curiosity. It smelled awful, and the BPS lined can had an awful smell despite the ingredients being: water, salt, baking soda, and no suspicious preservatives.
In my experience phenylephrine is worse than useless. Not only does it do nothing for congestion, but it makes me feel wired in a bad way and unable to sleep for at least 24 hours. I hate phenylephrine.
No worries, "Meth" was largely unknown in my area, until you guys exported "Breaking Bad". Roughly a year or two later, it started to be available here as well. Thanks for that, media industry, that was a wonderful move! /s
Phenylephrine doesn't work though. It never did. It was "pushed" as an alternative to pseudoephedrine which can be used to synthesize meth, but afaik every single study done on this shows that phenylephrine does absolutely nothing, it's a placebo drug. The faster it's phased out the better.
So a useless drug has made billions and took 30 years to be taken off the market . And who knows what damage it’s done ? Can we go back to being suspicious of pharmaceutical companies and the fda ?
It's rather annoying that the only actually effective nasal decongestants are amphetamines or otherwise closely related compounds. Sudafed is great for daytime relief, but there really is no good sleep time decongestant. Sure Nyquil is a thing, but it just relies on the antihistamine to produce drowsiness without any actual decongestant effect. And Dextromethorphan is arguably even more useless than Phenylephrine since at least the latter could conceivably be effective if you shot it up.
I’ve hearing great things about this new drug called placebo. You can apparently prescribe it for anything and in many cases it’s just as good as existing medications.
Context for readers from countries where this isn't an issue, or anyone who hasn't followed decongestant news: one of the most effective decongestants is called pseudoephedrine.
https://en.wikipedia.org/wiki/Pseudoephedrine
In the past this was easily available, with the most popular brand being Sudafed. My parents always told me that one should take Sudafed when flying after having had a cold, in order to avoid severe ear pain from the pressure changes, but people would also obviously take it when not flying, just in order to reduce the discomfort of the congestion itself.
Pseudoephedrine is very effective. It is also used to synthesize the somewhat related illegal drug methamphetamine ("meth"). Historically, meth manufacturers would hire people to buy large amounts of pseudoephedrine pills at pharmacies and supermarkets, then grind them up and synthesize meth from them.
In order to deter this, authorities in the U.S. restricted the availability of pseudoephedrine, while not making it prescription-only, by limiting the amount that people could buy, and requiring buyers to show ID and be put on a registry (which law enforcement could use in investigations). I think this is the only drug that is treated this way. Some people stopped buying pseudoephedrine entirely, either because they were offended by these rules or because they were afraid that they could wrongly be implicated in meth investigations if they appeared to buy it too often.
The pharmaceutical industry produced an alternative called phenylephrine, the substance that this proceeding relates to. Most manufacturers of pseudoephedrine-based drugs, including Sudafed, formulated alternative decongestants using phenylephrine. There are no legal restrictions on phenylephrine drugs; one can buy them anonymously and in any quantity. Customers have complained for years that these are much less effective than the original formulations.
A couple of years ago this regulatory authority started looking into the question of whether phenylephrine is actually completely useless as a decongestant (rather than just much worse than pseudoephedrine). Their preliminary review of studies suggested that it is probably, in fact, useless. This proceeding is now proposing to ban it on the grounds that it's ineffective and so people should not be encouraged to buy and use it as a medicine for purposes for which it doesn't actually work.
(There doesn't seem to be much corresponding initiative to remove or reduce the restrictions on pseudoephedrine.)
So at least here in Germany, we pretty much all use nasal spray with xylometazoline, and it's very effective as it also binds to adrenergic receptors. It does not seem to be available in the US, and at least from a cursory search I cannot find out why...?
EDIT: After looking a bit more, the simple answer seems to be that it's not FDA approved for nasal congestion, and since there's not much money to be made, there's simply no incentive to go through the costly approval process..
They have oxymetazoline but I think the problem with this class of decongestants is that it is ineffective and dependency is basically guaranteed if used for more than a couple of days
Oxymetazoline is different from Xylometazoline, although it was derived from it. Xylometazoline is pretty harmless for adults when not used over extended periods (it is advised to not use it longer than 6 days, but that will cover your typical cold). It is true that if you take it regularly over extended periods, you will have a rebound effect and your nose will get congested when not taking it, so in that way, you develop a "physical dependency", but that's obviously much more harmless than other medication dependencies. Getting off a Xylometazoline dependence means that you'll have to deal with a congested nose for a few weeks...
I don't see from your comment how the risk from congested nose for a few weeks deems it "harmless" for you. Two fully congested nostrils is hell for one night alone, imagine a few weeks of that. A few weeks of terrible sleep, if any. It's torture.
It can also cause permanently enlarged turbinates with chronic use.
I said it's more harmless than other medication dependencies, like getting hooked on pain medication or benzos. Even here in tightly regulated Germany, Xylometazoline can be bought without a prescription. It is very effective and, compared to other drugs, pretty harmless.
Look, there are always extreme cases. Just look up how many people need a liver transplant or even die each year from misusing paracetamol. So should we make it a prescription drug? Maybe, I don't know, it's always a trade-off.
Worse, the symptoms gets worse after you stop using it, see rhinitis medicamentosa.
Many people have used decongestants so much they cannot quit them or will have to suffer weeks of nasal congestion. I risked going through that; later I swore I will never touch one ever again.
I’ve wondered this also. As an American who lived in Germany and found this while living there, I can attest that it’s quite effective for me. There are other quite useful and safe drugs that are not available in the US.
There are nasal sprays in the US - and yes they are more targeted and better in general than pills. But Americans love their pills ... almost as much as Germans love their homeopathic remedies :-)
Good summary. To add to what you've said, Sudafed (as an example brand name) opens your eustachian tubes which are passages from your inner ear to your throat. If you think you might be getting an ear infection, Sudafed increases draining and potentially helps prevent a worse infection. As mentioned, it helps air equalize to the atmosphere via these tubes. If you make a yawning motion now and hear your ears crackle, that's the air moving through your eustachian tubes. You'll notice that crackling decrease when an ear infection may be imminent. I tried the useless alternative and discovered on my own that it was, indeed, useless. And it was quite expensive, with great marketing on the box.
I read this and was puzzled, until I realized that you are talking about the pills. The nasal spray is effective, although probably not more effective than a saline solution.
> although probably not more effective than a saline solution
I guess saline is a baseline against which effectiveness should be measured here, especially since nasal sprays are usually saline plus something. (I guess? Not sure about Sudafed specifically.)
I'd argue that saline should be the panacea here. I doubt very many people do at-home saline rinses with filtered, sterilized water and a simple mixture of salt and baking soda.
Do people really want to spray PFAS water directly into their mucus lining?
I bought an Arm and Hammer Saline spray out of curiosity. It smelled awful, and the BPS lined can had an awful smell despite the ingredients being: water, salt, baking soda, and no suspicious preservatives.
In my experience phenylephrine is worse than useless. Not only does it do nothing for congestion, but it makes me feel wired in a bad way and unable to sleep for at least 24 hours. I hate phenylephrine.
No worries, "Meth" was largely unknown in my area, until you guys exported "Breaking Bad". Roughly a year or two later, it started to be available here as well. Thanks for that, media industry, that was a wonderful move! /s
Discussion (136 points, 76 comments) https://news.ycombinator.com/item?id=42083559
The brands who have continued to sell this ingredient should be considered untrustworthy. It's basically fraud.
Do we know the story around the people who pushed this? (EDIT: By "this" I mean phenylephrine.)
Had they never had a stuffy nose?
Phenylephrine doesn't work though. It never did. It was "pushed" as an alternative to pseudoephedrine which can be used to synthesize meth, but afaik every single study done on this shows that phenylephrine does absolutely nothing, it's a placebo drug. The faster it's phased out the better.
How it was approved in the first place should have been reviewed
So a useless drug has made billions and took 30 years to be taken off the market . And who knows what damage it’s done ? Can we go back to being suspicious of pharmaceutical companies and the fda ?
It was on the market more like fifty years.
Well, it doesn't work.
It's rather annoying that the only actually effective nasal decongestants are amphetamines or otherwise closely related compounds. Sudafed is great for daytime relief, but there really is no good sleep time decongestant. Sure Nyquil is a thing, but it just relies on the antihistamine to produce drowsiness without any actual decongestant effect. And Dextromethorphan is arguably even more useless than Phenylephrine since at least the latter could conceivably be effective if you shot it up.
The US government, hard at work.
Next up: FDA proposes ending use of panaceas marked as overpriced drugs.
I’ve hearing great things about this new drug called placebo. You can apparently prescribe it for anything and in many cases it’s just as good as existing medications.
Well, I guess I’m here because of one of these miracle drugs. My kidneys would have crapped out year ago without it. I guess call me a fan…
It's also a great band!
Next up, eliminating the work of the Fiendish Fluoridators