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.
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.
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.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine
https://www.bu.edu/articles/2023/phenylephrine-cold-medicine-decongestant-ineffective/
https://www.nbcnews.com/health/health-news/fda-panel-says-common-counter-decongestant-phneylephrine-doesnt-work-rcna104424
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