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.
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.
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.
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.
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.
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
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
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.
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
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.
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.