How Two Pharmacists Figured Out That Decongestants Don't Work
How Two Pharmacists Figured Out That Decongestants Don't Work
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
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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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