Phenylephrine, a common decongestant in medicines is no better than a placebo when taken orally, says a US FDA advisory panel
by Wes Davis
A key cold medicine ingredient is basically worthless
The FDA’s 16-member advisory panel unanimously voted yesterday that oral phenylephrine, a common active ingredient in cold medications, is no better than a placebo for treating congestion.
Link to the article
The call by the panel sets up potential FDA action that could force the removal of certain over-the-counter medications containing the ingredient — including certain formulations of Mucinex, Sudafed, Tylenol, and NyQuil — from store shelves.
But FDA may hold off for many months, pending contested findings by drug makers and other considerations.
Data
Newer data from studies the panel says are more consistent with modern clinical trial standards showed phenylephrine simply “was not significantly different from placebo” in the recommended dosage, including trials from 2007 that the FDA had reviewed when considering the drug after a citizen petition prompted it to do so.
Bioavailability
The panel cited the drug’s low bioavailability, a term referring to qualities that allow the drug to be absorbed by the human body, as the main reason the drug should be removed from the market.
Jennifer Schwartzott said the drug “should have been removed from the market a long time ago,” while Dr. Stephen Clement said that although the drug itself isn’t dangerous, its usage by patients should be considered unsafe because it potentially delays actual treatment of disease symptoms.
Alternative
The panel cited pseudoephedrine as an effective alternative though while it’s technically available without a prescription, you must talk to a pharmacist to get it because, in large quantities, it can be used to make methamphetamines.
Finally, its super annoying this ever even got approved much less make it to primetime/blockbuster status (as the OTC replacement for pseudoephedrine). Everybody knew it was useless for the given indication (nasal congestion (stuffy nose/head) and yet, there we were. Refreshingly, sense has returned across the land
Interesting but anecdotally this is why I always felt like I needed to get the 'hard' stuff I guess. Thought I was just a damn junkie always going for the full strength decongestants but 'not significantly different from placebo' - are they calling for removal because it's essentially false advertising or because there are other risks than just blood pressure... I guess blood pressure is a big enough risk all things considered though.
It's being pulled because phenylephrine is basically inert. There's been a handful of studies that found this.
Phenylephrine is being removed because it is ineffective. It was synthesized and marketed as an alternative to pseudoephedrine because it had fewer side effects and could not be synthesized into methamphetamine.
This is going to sound stupid, but I didn't realize there was stuff behind the counter. I've been wasting my time with Nyquil!
The ironic part is you can get even "harder stufd" ie levomethamphetamine over the counter. It just really sucks and is super dangerous.
Hopefully this makes the pharmacists around me less stingy with pseudoephedrine.
Are they stricter than your local law? I've always been able to get the max allowed if I ask for it
They would always push the stuff that didn't work and they would make a stink if I asked for the max allowed. They had 6 packs there would give you if you said the stuff on the shelf didn't work. If you asked for a 12 pack they would make a stink. "You only need enough for a couple days, blah blah, you can come back if you need more, etc".
There are federal quotas per person, hence why they log your ID.
During covid i could walk up to the outside pharmacy window and buy it (I've also always needed the hard stuff lol) but now i have to go inside and walk up to the pharmacy counter.
Why. Just- why is that the line in the sand? So damn annoying.
No
Because of the CMEA of 2097 which outlines the requirements of PSE products as controlled substances requiring limits. Some states are more restrictive and it's not a matter of pharmacist discretion, but a matter of law.
Hey, Rich, I see you're a new user like me. I just wanted to let you know that users have labelled your comment as noise because it's just a one-word comment that doesn't contribute to the conversation, which is against the spirit of Tildes. You can read more about Tildes' philosophy here.
That's fine I've appended my post to reflect why PSE is treated this way since it's a controlled substance and some states have created a patchwork of more restriction based on the CMEA of 2007.
Max is 3.6g a day, which is 12 30mg Sudafed pills. They had these half packs they would try sell and when you asked for the max, they would throw a stink then give it to you.
That math doesn't work out.
12 * 30 = 360mg = 0.36g
So legally you're allowed to purchase 3.6g but the pharmacy will only let you purchase 1/10th of the legal limit?
This has been known for a long time. Glad the FDA is possibly taking steps to remedy this.
Hopefully acetaminophen is next, since it apparently doesn't actually relieve pain. Seems like it might only be effective at reducing fever.
Edit: there is more to the story with acetaminophen. See below for a well written comment with some good info!
I mean, that's just not true.
This recent and very comprehensive review of the various analgesic mechanisms of acetaminophen debunks that claim outright. It isn't a NSAID and has weak anti-inflammatory properties so may not be as effective for certain types of pain management - but even there, the authors cite some interesting work on one of the metabolites of acetaminophen which does act on inflammatory pathways.
The synergistic effect of acetaminophen and NSAIDs is also well established. See for example this review of post-operative dental pain concluded that the analgesic effect from acetaminophen and ibuprofen combined that was higher than each individually, and which rivalled several opioid formulations.
Acetaminophen makes me so sick when taken orally. Every time I have an injury or something, doctors keep trying to prescribe it over any other NSAID, when I tell them it makes me sick, they don't believe me.
I had it intravenously before a surgery last year, and it did nothing for the pain.
Apparently it may work slightly better than placebo for certain types of pain, but it does nothing for many other types of pain such as chronic pain, back pain, etc.
I remember reading this when the PE versions came out. It seems weird to me that the FDA is just now figuring it out. When I either distinctly remember reading this (similar) research back then, or appear to have time traveled with my knowledge.
This has been an open secret in pharmacy for a long time. We've known this doesn't work, and they really should throw away the whole cough and cold section.
Other things that don't work: homeopathy cold remedies, tessalon (for majority of people), guaifenisen (non dm mucinex). But people want to buy this shit so what do I know.
I've taken this a few times and each time I've felt absolutely horrendous afterwards. The first time, maybe I did or didn't associate the worsening symptoms with it, the second time I may have suspected it but still questioned if it was just a coincidence and probably one more time after that when I swore it off for good.
It just thins the mucus, makes it more watery. This makes it easier, in theory, to cough it up. It'll also make you cough more. Since it thins the mucus, you also make more of it. If you have thick mucus that is difficult to cough up, then it can help. But if you have a lot of thin mucus already, or aren't coughing (it's not going down the back of your throat) , then it might make things worse.
I've taken guafenisen out of desperation for some rather bad phlegm and congestion issues, and by god every time I took it the side-effects got worse. It just made my phlegm taste like bile, and when your body is making a ton of it there's no way you won't be tasting it constantly for the hours it takes effect. And the main effect it was supposed to happen was so faint that I'm not even sure it was working.
Um... what?
There HAS to be some BS here. I can attest to this from personal experience that phenylephrine is amazing. Or to be more accurate: whenever I get a cold (interestingly enough, usually when the seasons change), I say "I pray to the gods called DayQuil and NyQuil". Without those, I do NOT get any relief. And of course, phenylephrine is their main ingredient.
Now, if my understanding is correct, a placebo is just "you're taking nothing, but your body thinks it's something", which basically sounds like 'willing the issue away'... I'm sorry, but just 'Oh, I'm going to just will all these cold symptoms away' DOES NOT work- again, this is just my experience, but I can 100% attest to relief with these medicines, and without them I'm miserable, so something's not adding up.
Not to say that your experience isn't true for you, but you aren't taking PE straight, you're taking it along with a long combination of other drugs that can mask the perceived relief of PE itself and the congestion you get dissipating with time.
The article includes a link to the study results presentation that shows across multiple studies, notably larger than the one that got PE approved in the first place, its efficacy is nearly lockstep with a placebo and the body metabolizes nearly none of it.
Placebos aren't willing the issue away as they "work" only if the person taking them thinks they're the real drug. Which is why the tests are done blind where the study participants and administrators don't know what they're getting/giving. It's not saying that placebos work, it's showing that PE works as well as a placebo. That is, it doesn't.
Minor quibbling, but placebos actually have an effect even if you know it's placebo.
I was just about to say the same. I feel like placebo has gotten a worse reputation than it deserves — placebo can be potent, and it’s even been shown to have stronger effects based on delivery method — a placebo of a small pill will have some effect, but the same placebo delivered by a needle will have much larger relief effects.
I’m so fascinated by placebo and nocebo effects, and I think they’re too easily dismissed or disparaged by the general public.
Dextromethorphan HCl and Guafinesin are much more important in those medicines, afaik
You know what, this might actually be the case instead. I was looking into the ingredients the other day and I remembered phenylephrine... but now that I think about it, I also saw those as well. I could be entirely mistaken in what clears up the congestion.
Sort of. The placebo effect is well documented in the medical field, and is actually pretty fascinating IMO. Phrasing it as "willing the issue away" I think frames it unfairly as "if you just try hard enough you can make your body fix itself". A lot of the placebo effect has to do with the perception and expectation of the person, and then the body responding to the accompanying thoughts and emotions. Remember, we each construct our own reality because we're all basically hallucinating all the time.
There is also the inverse of the placebo effect, the nocebo effect. Which is where someone experiences lesser effect or no effect from an actual legitimate medication because of their preconceived notions. It can also increase the intensity of occurrence of side effects if the patient is keyed up to expect them.
There probably should have been half of an /s after the hallucination remark, as it was meant mostly to point out how much power our mind has on our perception of the world. Which reading it now 9hr later, isn't really clear and I should stop pontificating about the nature of reality right after waking up.
I was surprised to hear this too as I’ve always felt it worked for me. When I have sinus pressure and take it I get that popping feeling of my sinuses opening up. The cold and flu meds I take are normally just Phenylephrine and paracetamol (acetaminophen) which is surely not giving that effect?
I can’t stand pseudoephedrine. It makes me feel like I’m on speed or something, it’s awful. I hope that isn’t the only option in future
I don’t know if this is just your phrasing by chance, but yeah technically it can be synthesised into speed. One of the reasons that PE (edit to clarify: PE = phenylephrine) was created, to be a replacement that couldn’t be synthesised into speed.
Pseudoephedrine itself is a stimulant, no backyard chemistry required.
How was it approved the FDA in the first place?
Everyone must keep in mind: our framework of medicine is a "do-no-harm" model. Therefore, regulations based on medicine will greatly favour outcomes like this, i.e. approving useless drugs that can't be misused or overdosed on, rather than approving effective drugs that cause harm as a side effect.