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
It’s labeled as a nasal decongestant (your description of “opening up the sinuses” would fall into this, we’re talking about the same thing here, just different words), that is the indication it got for sale over the counter by the fda. It’s literally not allowed to be sold over the counter in its oral form for any other purpose by fda regulations (unless you count the topical form for hemorrhoids). Marketing a drug for unapproved uses is illegal.
I posted that study as an example, feel free to research on your own to look at the many negative studies in many similar situations showing it doesn’t work for this purpose. Here’s a meta analysis to save you some time:
The lack of evidence is why the fda pulled it, and why you’ll no longer be able to buy it over the counter in its oral form for the purposes of nasal decongestion.
It has other purposes of course, like being used intravenously to help increase blood pressure in the icu, or in the ophthalmology office to dilate pupil. But that’s not something you need over the counter. Taking it in it’s oral form at the over the counter dose to aid with nasal decongestion has no good evidence. I wasn’t implying it’s never used for anything else. That’s its only over the counter indication for its oral form I’m aware of. I think there’s a topical form in some hemorrhoid creams and the nasal spray form. The fda pull doesn’t affect any of its other uses.
Pseudophedrine is an approved over the counter nasal decongestant, and is still available (and has evidence backing it up for this use unlike phenylephrine). There’s also a nasal spray decongestant (afrin), but that can have some serious drawbacks if overused. Definitely read the packages on all of them carefully. I think the nasal spray topical form of phenylephrine might still be available though. All of the studies above refer to the commonly sold oral version.
Nasal means nose. Your sinuses are not your nose. Not sure why this is difficult? You’ve posted a second link to its use as a nasal decongestant.
“MEDLINE, the Cochrane Central Registry of Controlled Trials, EMBASE, International Pharmaceutical Abstracts, and the Federal Register were searched for English and non-English-language studies published through January 2007 that measured the effects of oral phenylephrine on nasal airway resistance (NAR) in patients with nasal congestion.”
Again, you’re making a distinction where there is none, we are talking about the same thing. So you’ll never find a study with the specific term you want, because that’s not the term used for that symptom in research.Your sinuses are a part of your nasal passage and nasal airway (nasal doesn’t just mean, literally in the nose in the front of your face and nowhere else in this context, it’s referring to the whole cavity), decongestants consrict blood vessels to shrink the size of tissues and to reduce production of mucus. There’s no such thing as an over the counter medication with a specific indication of “sinus congestion” versus “nasal congestion.” Phenylephrine never carried any special label as a “sinus” decongestant, that’s not an actual distinction anyone makes, it’s the same tissue. It’s like you’re saying “sure you have all these studies about global warming, but I was asking about climate change,” like yes, these refer to the same phenomenon.
Like here’s a label if you don’t believe me:
Look at the box of active ingredients: it says nasal decongestant (not sinus decongestant) is the indication. It refers to your whole nasal airway, including sinuses. That’s why under uses afterward it specifically mentions sinus pressure/symptoms. Nasal decongestant refers to relieving that symptom. This is my last comment on this chain because I don’t know what else to tell you. You’re misinterpreting terms here. And if you still don’t believe me, if the nasal decongestant indication didn’t refer to relieving sinus pressure, it would literally be illegal for it to be labeled this way, as drugs cannot be labeled for a non-FDA approved indication. But don’t worry there’s still plenty of alternative decongestants that do have actual evidence that can be used.
This is a whole “Shit Americans Say” conversation. I understand that you are struggling with the idea that meds can be used for other reasons, reasons that may not be allowed in your country.
However the headline saying a medication doesn’t work is false.
You have linked studies about breathing, do you breathe through your sinuses?
It’s labeled as a nasal decongestant (your description of “opening up the sinuses” would fall into this, we’re talking about the same thing here, just different words), that is the indication it got for sale over the counter by the fda. It’s literally not allowed to be sold over the counter in its oral form for any other purpose by fda regulations (unless you count the topical form for hemorrhoids). Marketing a drug for unapproved uses is illegal.
I posted that study as an example, feel free to research on your own to look at the many negative studies in many similar situations showing it doesn’t work for this purpose. Here’s a meta analysis to save you some time:
https://pubmed.ncbi.nlm.nih.gov/17264159/
The lack of evidence is why the fda pulled it, and why you’ll no longer be able to buy it over the counter in its oral form for the purposes of nasal decongestion.
It has other purposes of course, like being used intravenously to help increase blood pressure in the icu, or in the ophthalmology office to dilate pupil. But that’s not something you need over the counter. Taking it in it’s oral form at the over the counter dose to aid with nasal decongestion has no good evidence. I wasn’t implying it’s never used for anything else. That’s its only over the counter indication for its oral form I’m aware of. I think there’s a topical form in some hemorrhoid creams and the nasal spray form. The fda pull doesn’t affect any of its other uses.
Pseudophedrine is an approved over the counter nasal decongestant, and is still available (and has evidence backing it up for this use unlike phenylephrine). There’s also a nasal spray decongestant (afrin), but that can have some serious drawbacks if overused. Definitely read the packages on all of them carefully. I think the nasal spray topical form of phenylephrine might still be available though. All of the studies above refer to the commonly sold oral version.
Nasal means nose. Your sinuses are not your nose. Not sure why this is difficult? You’ve posted a second link to its use as a nasal decongestant.
“MEDLINE, the Cochrane Central Registry of Controlled Trials, EMBASE, International Pharmaceutical Abstracts, and the Federal Register were searched for English and non-English-language studies published through January 2007 that measured the effects of oral phenylephrine on nasal airway resistance (NAR) in patients with nasal congestion.”
Again, you’re making a distinction where there is none, we are talking about the same thing. So you’ll never find a study with the specific term you want, because that’s not the term used for that symptom in research.Your sinuses are a part of your nasal passage and nasal airway (nasal doesn’t just mean, literally in the nose in the front of your face and nowhere else in this context, it’s referring to the whole cavity), decongestants consrict blood vessels to shrink the size of tissues and to reduce production of mucus. There’s no such thing as an over the counter medication with a specific indication of “sinus congestion” versus “nasal congestion.” Phenylephrine never carried any special label as a “sinus” decongestant, that’s not an actual distinction anyone makes, it’s the same tissue. It’s like you’re saying “sure you have all these studies about global warming, but I was asking about climate change,” like yes, these refer to the same phenomenon.
Like here’s a label if you don’t believe me:
Look at the box of active ingredients: it says nasal decongestant (not sinus decongestant) is the indication. It refers to your whole nasal airway, including sinuses. That’s why under uses afterward it specifically mentions sinus pressure/symptoms. Nasal decongestant refers to relieving that symptom. This is my last comment on this chain because I don’t know what else to tell you. You’re misinterpreting terms here. And if you still don’t believe me, if the nasal decongestant indication didn’t refer to relieving sinus pressure, it would literally be illegal for it to be labeled this way, as drugs cannot be labeled for a non-FDA approved indication. But don’t worry there’s still plenty of alternative decongestants that do have actual evidence that can be used.
This is a whole “Shit Americans Say” conversation. I understand that you are struggling with the idea that meds can be used for other reasons, reasons that may not be allowed in your country.
However the headline saying a medication doesn’t work is false.
You have linked studies about breathing, do you breathe through your sinuses?
https://www.saintlukeskc.org/health-library/understanding-nasal-anatomy-inside-view
Here is a diagram to help, it labels the nasal cavity and the sinuses which it shows you are air filled chambers around your nose.
Are you brain damaged or something?
Took too much phenylephrine 😔