this post was submitted on 23 Dec 2023
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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.

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[–] monotremata@kbin.social 66 points 2 years ago (1 children)

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.

[–] MaxVoltage@lemmy.world 53 points 2 years ago (2 children)

Capitalism bro pharmacies are selling snake oil now a days and need to be Litigated Heavily

[–] SoleInvictus@lemmy.world 12 points 2 years ago (1 children)

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.

[–] oDDmON@lemmy.world 4 points 2 years ago

CVS, lookin’ atchu.

[–] Alexstarfire@lemmy.world 3 points 2 years ago

Yea, cause no one sold snake oil back in the day. Just a bunch of honest Joes with the government holding them back.

[–] Got_Bent@lemmy.world 27 points 2 years ago

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.

[–] workerONE@lemmy.world 25 points 2 years ago* (last edited 2 years ago) (2 children)

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/

[–] Alexstarfire@lemmy.world 5 points 2 years ago

Sudafed isn't outlawed. It's just behind the counter.

[–] VeganSchnitzel@lemmy.world 4 points 2 years ago (1 children)

It's paywalled, does anyone have the article?

[–] Shelbyeileen@lemmy.world 24 points 2 years ago

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

[–] BradleyUffner@lemmy.world 17 points 2 years ago (1 children)

Weird... I figured it out by taking some when I was congested and noticing that it didn't work.

[–] c0mbatbag3l@lemmy.world 2 points 2 years ago

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.

[–] 01189998819991197253 10 points 2 years ago

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.

[–] el_abuelo@lemmy.ml 2 points 2 years ago

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.