FDA proposes ending use of oral phenylephrine as OTC nasal decongestant

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.)

One of my favorite papers is "A simple and convenient synthesis of pseudoephedrine from N-methylamphetamine" [1].

This is a satirical paper. Because pseudoephedrine (i.e. the good decongestant) is very difficult to obtain due to restrictions, but "N-methylamphetamine can be procured at almost any time on short notice", the paper describes how to synthesize pseudoephedrine from meth with a procedure that looks valid.

[1] https://improbable.com/airchives/paperair/volume19/v19i3/Pse...

I remember complaining to my friends about how frustrating it was to hear that a medicine I frequently used turned out to be placebo, exactly one year ago today. Opened this article up, I'm currently taking the _exact same_ one in the article photo - it's what I had lying around and I had forgotten the name of the "bad" sudafed (it's sudafed PE). They need to take it off the shelves quicker. Every day is tens of thousands of more people who are scammed.

Putting my money where my mouth is and leaving a comment on the FDA proposal...

Way overdue. I wonder if the purveyors of this fraud have ever been sued.

One refrain I got tired of hearing was that it "wasn't a safety issue." WRONG. Anyone who has ever had a ruptured eardrum can tell you that it is 100% a safety issue.

If you're about to take a flight with any congestion, you're relying on decongestant to save your ears. I've had ruptured eardrums; it's probably the worst pain I've experienced. I had to take a flight a couple years ago with only this crap, and must have come extremely close to rupturing them again. It was EXCRUCIATING.

As long as we're giving decongestant advice, in my experience a neti pot (sinus rinse) really helps.

I also take pseudoephedrine when things get bad. I'm not trying to push a natural stuff only approach.

The neti pot really seems to reduce the odds that sinus congestion will spiral into a terrible sinus headache.

Do be aware of the need to use sterilized water to avoid a possible dangerous infection, though. Distilled water is the easiest way.

You can still get pseudoephedrine containing Sudafed in UK sometimes, I've had difficulties finding it, but they package it almost identically to the phenylephrine containing placebo.

To me this has always seemed like obvious fraud.

We don't have class actions in the UK, but perhaps in USA there's a chance of punishing this sort of behaviour going forward?

Basically they took the active ingredient out, added a similarly sounding chemical, continued to sell the new known-ineffective chemical in the virtually the same packet, under the same trade dress and branding...

Pseudo was really effective for me. When I first bought Sudafed after they took the active ingredient out (of the easy to find product) I thought I'd misremembered, took a couple of illnesses before I twigged, then some very careful analysis of packaging to make sure to get the actual medicine.

So stupid. It was plainly obvious how ineffective it was, compared to pseudoephedrine, anytime you got sick.

I'm sure this will be unpopular, but I think the real problem with Phenylephrine is that it isn't dosed appropriately in standard formulations.

The standard 10mg dose is too low. Decongestants work by constricting blood vessels, which inherently increases blood pressure as a side effect.

Pseudoephedrine at standard doses is known to raise blood pressure slightly. Phenylephrine at standard doses (10mg) shows no such effect (Source https://journals.lww.com/ebp/abstract/2018/03000/how_much_do... )

Phenylephrine does increase blood pressure when delivered by IV at doses that work. The oral 10mg dose just isn't enough to get absorbed and do anything.

It's not that phenylephrine is ineffective, it's that it's underdosed in the oral formulation.

I've noticed that in the UK all phenylephrine based OTC medications also contain paracetamol (acetaminophen) and often caffine. They are just an expensive way to buy two very cheap compounds with an added bit of placebo effect from the flashy packaging.

I can't take pseudoephedrine due to high blood pressure and I've found that the most effective thing for me, especially at night, is paracetamol, a blast from a nasal spray, and one of those nasal strips that help keep your nostrels open a bit more. It's not quite up there with the real Sudafed, but it's generally enough to get me a good night's sleep.

Back to Pseudoephedrine! It's behind the counter at your local pharmacist.

The brands who have continued to sell this ingredient should be considered untrustworthy. It's basically fraud.

Wonder how many people "fell" for it though.

I remember, many years ago, that I got some Antihistamine tables with Pseudoephedrine to take in 'light' emergencies for my allergies, cat hair in my case. I wasn't going to fall over like other people but have trouble breathing and a runny nose, so every time I visited people with cats, I could take one and everything was fine. When they banned it and my supply was used up, I got something with Phenylephrine and it just did... nothing. Then 5min of online research told me just as much.

Everyone in the pharma and regulatory world has known this stuff is worthless for years. I feel like the pharma industry should be severely fined for knowingly perpetrating a fraud on the public. Sadly, they would likely be able to defend themselves on the grounds that the FDA allowed it.

Meanwhile generic decongestants like Ambroxol that actually work are too expensive to go through FDA approval.

https://marginalrevolution.com/marginalrevolution/2024/05/th...

Maybe a shorter duration(<5yrs) patent(for lack of better word) for unapproved generics might do the trick.

I can't pronounce either one of the Sudafed substances. One time, an old lady asked me which Sudafed work for her as she pointed to a shelf full of Sudafed plus other decongestant drugs. I told her just buy the one that you need to take the flyer and bring it to the pharmacist to get it. Others are just scam. The real one is used to make meth so they put it behind the counter.

She was surprised that the US gov would allow fake decongestant to be sold.

My anecdata is that, though it's not as effective as pseudoephedrine, phenylephrine actually is effective in an inhaler, and a helluva lot better at clearing up a stuffy nose than "scents and essential oils". Of course, a cylindrical inhaler with a wick inside it doesn't go near my digestive tract... Now I'll have to look around for a replacement inhaler, something quick enough to avert choking-panic. Thanks, CVS.

Didn't see any one talk about it but French health agency recommended all pharmacists and doctors to stop issuing Pseudoephedrine for colds as there is supposedly increased risk of heart attacks and strokes. It was only for people with high BP but seems like it's now for general population too.

Source: https://www.rfi.fr/en/france/20231024-french-health-agency-w...

Thanks to the Administrative Procedures Act, and per the release from the FDA, the proposal will take some time. Comments are accepted until May 7, 2025. If the government moved with all legal alacrity, the order might get finalized by this time next year, that's if there are no lawsuits, petitions, etc.

I mention this because I can't help but feel the APA takes too long when an agency is doing something proactive for the public good. This should take sixty days, not years, because it's not a removal of a product for safety reasons, that's often done via the FTC.

There is a hole between FDA's authority to create and amend regulations, order the removal of products due to safety, and what should be a more routine streamlining of the FDA cleaning up..

APA - 5 U.S.C. §§ 551–559

Not sure if it's still possible, but in eastern europe back in 2010s you could buy bottles of liquid ephedrine nose drops without a prescription. The pharmacists would get raw ephedrine and mix it in the back, filling the generic nose drop bottles. Tho they'd only give you 1 a month or so, looking at you suspiciously if you came multiple times in a row.

Back when I was obsessed with sports and being the peak athlete I can be, I'd go to the different pharmacies around town and buy a bunch of nose drops. These would get mixed in with coffee to get a dumb version of EC stack. Not sure if it was worth it, but it definitely had me wired to the gills.

Clearly placebo for me, I guess? It's wild how many people are saying phenylephrine is completely ineffective. It saved my ass during a really long COVID stint. It was impossible to find by itself but when we finally found it we bought 2 boxes because we use it and, for us, it works wonders... Hope they release something else better I guess.

Looking forward to the FDA recommending ivermectin to take its place in late January 2025.

I have tried many nasal sprays, but what is really effective is a salt in water solution (slightly salty to taste) and a 10 ml syringe. Simply inject it into each nostril so that the water comes out through the mouth, a couple of times a day. Cleans out all the garbage really well.

Among the medications, Flonase spray is effective, but saltwater is enough most of the time.

phenylephrine is still pretty effective as a topical nasal spray. so don't write it off if you see it in that form.

Cue:

- the entry of trolls everywhere demanding that they can keep the médecine they've been using for ages

- the new administration's agreeing with "popular demand" and disagreeing with the FDA, because that's their thing

- and the companies selling the drug be like "uh, ok, fine".

At least it will be an interesting distraction from trying to fix the opioids epidemic ?

Do we know the story around the people who pushed this? (EDIT: By "this" I mean phenylephrine.)

Had they never had a stuffy nose?

There's also https://arstechnica.com/health/2024/11/fda-proposes-ditching...

(via https://news.ycombinator.com/item?id=42083559, but we merged the comments hither)

Does anyone else feel like dayquil is an effective decongestant? I do. I can literally feel the gunk running down from my sinuses to the back of my throat when I take it. Confusing to me cause it's phenylephrine, which is what the article states is ineffective. I've had this experience after reading these reports about a year ago.

Phenylephrine worked great for clearing my mucus overproduction. Unfortunately, this has little to do with allergy relief, so I can see why many here hold that it's ineffective. I can imagine how frustrating it must be to have actual allergy issues and be prescribed something that doesn't solve the problem.

Side question; is phenylephrine applied topically under the eyes good for reducing the appearance of dark circles?

I've seen some anecdotes suggesting this due to its vasoconstrictive effects

It was obvious to consumers very quickly that it didn't actually do anything. Astonishing this charade went on so long.

I find the Sudafed PE is useless but the Alka Seltzer with phenylephrine works and works really fast.

It's been definitiely shown since at least 2010 that phenylephrine is useless for this purpose. How in the world did the FDA let the decongestant industry push this drug for 15 years before coming down on it?

It doesn't relieve nasal congestion and it never did. While it's certainly safe, it's not even slightly effective.

I knew this stuff didn't work the first time I bought it by accident because I thought it was normal Sudafed. Amazing its lasted this long

Just as a reminder, you are completely allowed to buy pseudoephedrine without a prescription, you just have to ask your pharmacist. My local pharmacy keeps it behind the counter already pre-compounded, and it's cheap and effective. One of those little things that I never used to purchase because I was somehow not certain if I could actually get it. Yes, you can.

Finally. I hope this reaches Australia and the rest of the world. Phenylephrine doesn't work, it never worked, it's obvious that it doesn't work, it's a literal scam, and the companies selling it are fraudulent.

Great. I always have to explain to people not to buy this crap and get the good stuff instead

Good. I get food poisoning symptoms from it, but it's so popular that my other options are limited.

The outrageous thing about this is that people are getting accused of a crime for trying to buy the effective drug.

Well, it doesn't work.

Next I hope they do cough medicines, I looked a few years ago when I had a cough and it seems like literally none of the OTC ones are more effective than placebo.

Make pseudoephedrine great again.

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 ?

Am I taking crazy pills, because I've been taking PE for years and it works just fine? Like yes the behind the counter stuff is stronger but it also comes with more annoying side effects.

I use it to sleep during allergy season and I can tell when I don't take it when I mouth breathe the whole night. I might try some experiments to see if I can tell but I didn't think you could placebo while sleeping.

For most of my adult life, I was "addicted" to sudafed (pseudoephedrine, not phenylephrine). I had absolutely horrific sinus problems. Could never breathe, tons of sinus infections, etc etc. Things like sinus rinses (not a netipot which is gravity driven, but a positive pressure squeeze bottle) helped, but it was still a major inhibitor in life.

I got a new ENT, and I started getting a quarterly "chemical nasal cautery". It has ABSOLUTELY changed my life. I can breathe sooo much easier, and I couldn't recommend it enough to anyone with persistent sinus issues. It is super easy. It doesn't even kind of hurt, the most mild of stings if anything at all. Doc will spray a lot of afrin up your nose, then lidocaine, then carbolic acid which kills a bunch of your immune cells (so they can't overreact to tree pollen and make you miserable). You get it done once a month for three months, then once every 3 months thereafter.

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.

Really hard to trust the FDA when they let this obvious scam go on for so long.

Just take N-A-C instead. Actually works and your liver will be happy as well.

And yet homeopathy stuff is legal and often mixed in on the shelf with actual drugs.

Sigh. Still an improvement.