A loophole in FDA processes means older drugs like the ones in oral decongestants weren’t properly tested. Here’s how we learned the most popular one doesn’t work
In 2005, federal law compelled retailers nationwide to move pseudoephedrine, sold as Sudafed, from over-the-counter (OTC) to behind it, so as to combat its use in making illicit methamphetamine. This move changed the formulas of cough and cold medicines in the U.S… It also led me and my colleague Leslie Hendeles to prove that pseudoephedrine’s replacement, oral phenylephrine, was ineffective as a decongestant.
We petitioned the Food and Drug Administration (FDA) twice, yet it took the agency more than a decade and a half to act on our findings.
In September, an agency advisory panel finally agreed with our conclusion that this compound did little to quell congestion and recommended that products containing it be pulled from shelves. If FDA acts on this recommendation, oral phenylephrine could be the first OTC drug approved under the agency’s “monograph” process to be discontinued. But in the meantime, millions of people have been trusting the FDA’s OTC regulatory process to ensure that medications work, but instead have been wasting money for nearly two decades on ones that don’t.
It drove me nuts that they marketed phenylephrine as “Sudafed PE.” The name Sudafed was derived from the term pseudoephedrine. Once it contains no pseudoephedrine, it becomes pretty misleading to keep that name.
Capitalism bro pharmacies are selling snake oil now a days and need to be Litigated Heavily
I’m still floored that major pharmacy chains in the United States sell homeopathic products. If that isn’t a breach of trust, I don’t know what is.
CVS, lookin’ atchu.
Yea, cause no one sold snake oil back in the day. Just a bunch of honest Joes with the government holding them back.
Give me ye olden days cough sizzurp
You can still get that. It’s just called codeine now. Or am I thinking of heroin? Or is it cocaine? Well it’s one of them. Just give each one a go. They’re petty harmless.
No I want this one.
For a lift? Alternate with this one:
https://flashbak.com/wp-content/uploads/2020/07/Benzedrine-Inhalers-1200x594.jpg
Hahaha, amphetamine inhaler! I was born far too late, the golden age of drugs is long gone.
Specifically that phenylephrine doesn’t work, not all oral decongestants.
Isn’t phenylephrine currently all the OTC oral decongestants? I checked my medicine cabinet and all the cold medicine that I have that claims to also be a decongestant uses it.
It used to be pseudoephedrine but that got restricted/replaced with phenylephrine due to it being a convenient meth precursor.
No, pseudoephedrine is still OTC. It’s just literally over the counter and you have to ask a pharmacist. It’s not out on the shelf. You don’t need a prescription or anything though.
In Oregon they actually did require a prescription for it until January 2022. A lot of folks in Portland would just drive across the river to Washington to buy it OTC.
Yup, they’ve been scamming us for years and getting away with it.
Nah, you can still get Sudafed with the pseudoephedrine in it, you just have to ask the pharmacist for it. And they will probably treat you like a criminal and ask for your ID to purchase it.
Where I live, they ask for ID for any cold medication (not Sudafed as I had no idea you could ask for it until others responded). It is quite annoying when you forget about it and try to use the self service register.
Once pseudoephedrine was moved behind the counter in the 2000s, that left phenylephrine as the only remaining oral decongestant sold on the shelves of pharmacies, grocery stores, convenience stores and other retail outlets. Makers of oral decongestants and cold remedies reformulated their products to contain phenylephrine, sold as Sudafed PE, among others, instead of pseudoephedrine.
Right, I know. They restricted pseudoephedrine because people were making meth from it and substituted phenylephrine. However pseudoephedrine actually worked, unlike phenylephrine.
Also specifically when phenylephrine is taken orally, the FDA did not examine its use in nasal sprays which are still considered effective for short term use
https://www.bu.edu/articles/2023/phenylephrine-cold-medicine-decongestant-ineffective/
Fuck Sudafed PE, but I’ll add some irl experience to the science:
Had about 2 weeks of painful congestion that kept me awake all night almost a year ago now (it was so bad my sleeping brain thought I was being choked and would force wake me up) and tried PE because my local pharmacy was totally out of regular Sudafed. It didn’t work, shocker. But then they suggested I try the nasal spray with it, and I almost didn’t listen to them.
Not gonna say it was some magic drug or that it was even in the same ballpark as actual Sudafed, but it DID make it so I could move around and actually get to the pharmacy further away that had real Sudafed, and that’s more than the PE PILLS can say or do
What other otc options exist?
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Fucking war on drugs.
As if someone buying a box of pseudoephedrine is going to become Walter White, when organised crime makes meth by the tonne.
It’s really hard to buy pseudoephedrine in many countries now, meanwhile organised crime is making more meth than ever.
It’s outdated at this point since the era of homemade meth has come and gone, due to the excessive supply of higher quality from Mexican cartels.
Well, yes, that is an important distinction from the headline. The behind the counter vs over the counter distinction is minor but also important as well.
I think that was the point of the question: there is only one real option, pseudoephedrine.
Are there decongestant nasal sprays or something? I’ve been taking phenylephrine because I believed it worked–even though it was a placebo --and never looked at other options. I don’t tolerate pseudoephedrine well.
Phenylephrine somewhat works as a nasal decongestant
There are other comments with some science links and I can confirm through experience that comparing PE PILLS to PE spray the spray actually does something
Not nearly the same effect as pseudoephedrine
There’s also Fluticasone (Flonase) but I wouldn’t recommend that unless you’re desperate or rich (in my area a small bottle of PE spray costs like 5 bucks, the base Flonase that has about half the drugs in it is almost 20)
I swear by nasal sprays that contain xylometazoline. If I get a cold, it’s the only thing that lets me actually breathe so I can fall asleep.
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Didn’t you hear? Massive shortage on. Most of us can’t get our medicine. (And it’s not “medicine” jackass. It’s the difference between me being “employable, constructive member of society” and a “disaster in human form.”)
You mean a schedule II drug which is only permitted because it has such extreme relief of the condition it treats?
You could always get ‘mormon tea’ which is high in ephedrine.
Sure do.
Sucks that people abuse it or are only using it for “weightloss” but for some people who actually have adhd being off/on those medications is basically like bowling with a bouncy ball vs bowling with a regular bowling ball and the gutter guards up.
Just have to hope you’re bowling in the right lane but at least you’ll be bowling effectively
You are right
Pretty much since 2005, I immediately realized that pseudoephedrine worked way better than whatever they replaced it with, so I went ahead and began signing my life away at the counter to continue getting it and using it. And by worked way better, I mean the replacement didn’t do shit.
I don’t particularly like announcing to the government in writing that I’ve got the sniffles, but damnit, it’s actual relief from symptoms, so declare my snot balls I do and I’ll continue to do so.
On a related note when they outlawed Sudafed (ephedrine), makers of methamphetamine started using a different manufacturing process that results in meth that is slightly chemically different, and it makes people really crazy, really fast. Meth always caused psychosis (craziness) but the new version that’s not made with ephedrine is way worse.
https://www.theatlantic.com/magazine/archive/2021/11/the-new-meth/620174/
Sudafed isn’t outlawed. It’s just behind the counter.
New Zealand banned pseudo, because of meth problems, and my family there won’t even use decongestants because it won’t work. They still have meth problems, but no relief from illness. The melatonin is prescription only, too, which is weird to me
Weird… I figured it out by taking some when I was congested and noticing that it didn’t work.
I was gonna write some version of this lol
Yeah it just doesn’t seem to have any tangible effect, no better than a placebo.
For me, phenylephrine actually makes my congestion worse (in the sinuses and in the chest) and leads to longer recovery times. Did you know that some tussins contain phenylephrine? Yeah… I was too miserable the last time I was sick to read the actives list. Paid for it with an added week of recovery. Screw phenylephrine, those who approved it for sale, and those who added it to their meds.
This is infuriating.
Sure - I noticed that my congestion had done fuck all…but I assumed that if I hadn’t taken the BS drug that I would have been even worse! To learn that I could have taken cheap-as-chips aspirin and it had the same effect as the BS tablets for 10x the price has me frothing at the mouth.
Now I need to figure out how I pay 100x the price to get the the tablet that actually fucking works.
I take Claritin and it absolutely works. Is this not the same thing or am I missing something?
EDIT: for all the idiots downvoting a simple question…
Claritin-D has pseudoephedrine in it. THAT is why I asked my question. If you all want more people posting in lemmy, best not to insult people for asking simple questions like you used to on Reddit.
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Claritin-D is a decongestant and has pseudoephedrine
Careful, these kids don’t like to be corrected.
Ahh. Okay.
You could start by reading the body of the post and see what drug is mentioned. Then compare that to your bottle of Claritin.
Lighten up man. It was just a simple question. It would have taking you far less effort to just not say anything at all.
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For the record- Claritin-D has pseudoephedrine in it, genius. That’s why it’s relevant.
Next time, don’t bother posting without checking your own relevance.
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CrayonRosary provided instructions for how to tell. If this change was relevant. And they were respectful about it.
Nah, I was being snarky.
And Claritin-D has pseudoephedrine in it. Which leaves my question unanswered.
”pseudoephedrine” DOES NOT EQUAL ”phenylephrine". How is your question not answered?
5 second google results:
Claritin-D 24 hour extended release tablets contain 10 mg loratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate in an extended-release core. Claritin-D 24 hour extended release tablets are white to off-white oval, biconvex, coated tablets branded in black with “CLARITIN-D 24 HOUR”.
Read my other reply, dumbass.
A simple question which revealed you were too lazy to read the article before asking questions. You’re the worst kind of Lemmy user. Why should other people do the work for you just because you’re too lazy to do anything other than read the headline?
You deserved a little bit of snark. Take your licks and go read the article now.
I read the article, asshole. Claritin-D has pseudoephedrine in it. Which is what I asked what I asked.
YOU are the worst kind of lemmy user. You’re an arrogant blowhard that has to say shit when they could have just scrolled past and ignored what you didn’t understand.
Take your likes and delete your embarrassing response.
Claritin-D has pseudoephedrine
You clearly didn’t read the article which says nothing about pseudoephedrine not working. If you had, you wouldn’t have had to ask. Can you not tell the difference between the words pseudoephedrine and phenylephrine?
Even if we give you the benefit of the doubt, and you were asking a sincere question after having read the article, it was a really poor one. You could have mentioned what your confusion was, but you were to lazy to do even that.
what you didn’t understand.
Funny.
Take your likes
Take my what now?
It took 5 seconds on google:
Claritin-D 24 hour extended release tablets contain 10 mg loratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate in an extended-release core. Claritin-D 24 hour extended release tablets are white to off-white oval, biconvex, coated tablets branded in black with “CLARITIN-D 24 HOUR”.
Stop being stupid.
Did you still not read the article? Pseudoephedrine WORKS! Oral Phenylephrine DOES NOT! Claritin does NOT contain Phenylephrine. The article says nothing about pseudoephedrine not working, and yet you still don’t get it!
No one ever said anywhere that Claritin-D doesn’t contain pseudoephedrine. No one! No one ever said pseudoephedrine doesn’t work. Who are you arguing against? Why are you so dense?
Article:
Phenylephrine doesn’t work.
You:
I swear Claritin works! I’m so confused!
Me:
Claritin isn’t phenylephrine, read the label.
You:
Nuh uh! Google says it contains pseudoephedrine!!
Me: 🤦♂️
Claritin is an antihistamine, this is about phenylephrine (Sudafed PE) which was used in just about every OTC daytime cold medicine.
Claritin also makes Claritin-D which is a decongestant that has pseudoephedrine
Claritin is an antihistamine, not a decongestant.
Claritin also makes Claritin-D which is a decongestant that has pseudoephedrine
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I am assuming you are mistaken and you meant Claritin-D, which does have pseudoephedrine so I don’t know why everyone is downvoting you… it’s also what I’ve always taken when I was congested and it works wonderfully.
Thank you for your response. I don’t know why either.
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