FDA reports Sudafed PE, et al, lack of efficacy

[Telly]

Oral administration of phenylephrine as an oral decongestant.

FDA report is here (big report, maybe start at page 31 for those really interested):
https://www.fda.gov/media/171915/download

My conclusion - The studies provided years ago that showed the efficacy of phenylephrine were poorly done to useless.

Not a surprise to me at all!

Some years ago, Pseudoephedrine Hydrochloride (the original Sudafed, and others including generics using PH) were put behind the counter, with registration and per-month limits applied to obtain them. Because some were using them as a base stock to create illegal drugs, to feed America's insatiable appetite for illegal drugs.
I am surprised that the law was never repealed.

Anyway, at the time of this change, I tried Sudafed PE (many other companies came up with their own, using the same non-useful replacement chemical, phenylephrine). I found it had no effect what-so-ever on my sinus pressure-induced headaches. Original Sudafed worked, the replacement was totally useless.

So I signed up, showed ID, etc., stayed with a generic original Sudafed. Sometimes pharmacy would be out of them. I kept enough stock to cover that. I don't take them that often, but there are times when I really need them.

Today's news brought the announcement of the FDA report. Long time coming.

 

[Montecfo]

I bought the Sudafed PE maybe once. Never again.

Agree, never worked.

 

[SecondAttempt]

I only used original sudafed for scuba diving, and really only my ex-wife. It worked great to open Eustasian tubes to facilitate pressure equalization. It's the same mechanism that alleviates sinus pressure so this non-medical-expert was pretty sure 20 years ago that this was a big scam to justify making the real stuff hard to get because of the war on drugs.

I've never run into difficulty buying it for diving and this past winter I was buying it in quantity without issue for a sinus infection just before and while on vacation. Never had any issue with pharmacists. But then again I don't think I look like the average meth dealer.

Mark my words there will be a class action suit about this with both big pharma and the government, FDA and DEA as defendants.

 

[disneysteve]

As a doctor, this is no surprise and long overdue. We’ve known forever that phenylephrine did nothing. I’ve always advised patients not to take it. If you need a decongestant you want pseudoephedrine. It’s a pain having to go to the pharmacy counter and show id and be limited on how much you can get but at least you’ll have a drug that actually works.

I hope they pull all of the products containing phenylephrine. There’s no reason to have them on the market.

 

[FLSUnFIRE]

Yep, it was garbage.



I'm just happy that the meth epidemic was stopped in its tracks by making it difficult for people to buy pseudoephedrine. Small price to pay for a world without drug abuse. </sarcasm>


Seriously, the pharmacist shortage has caused many places to limit the hours the pharmacy window is open and I've had trouble buying pseudoephedrine due to that. I tend stock up if I'm at Wally World or other places with generic when I see the window is open.

 

[Amethyst]

I used to use Sudafed and generics for congestion, but I quit when my ENT doctor said that such drugs dry out all the mucous membranes and really do more harm than good. She prescribed nasal Flonase, instead.

I also remember reading that a lot of women were using OTC PE as an appetite suppressant. Not my thing, but I guess it works for some? (OTC = over the counter)

Oral administration of phenylephrine as an oral decongestant.

FDA report is here (big report, maybe start at page 31 for those really interested):
https://www.fda.gov/media/171915/download

My conclusion - The studies provided years ago that showed the efficacy of phenylephrine were poorly done to useless.

Not a surprise to me at all!

Some years ago, Pseudoephedrine Hydrochloride (the original Sudafed, and others including generics using PH) were put behind the counter, with registration and per-month limits applied to obtain them. Because some were using them as a base stock to create illegal drugs, to feed America's insatiable appetite for illegal drugs.
I am surprised that the law was never repealed.

Anyway, at the time of this change, I tried Sudafed PE (many other companies came up with their own, using the same non-useful replacement chemical, phenylephrine). I found it had no effect what-so-ever on my sinus pressure-induced headaches. Original Sudafed worked, the replacement was totally useless.

So I signed up, showed ID, etc., stayed with a generic original Sudafed. Sometimes pharmacy would be out of them. I kept enough stock to cover that. I don't take them that often, but there are times when I really need them.

Today's news brought the announcement of the FDA report. Long time coming.

 

[Car-Guy]

Both the DW and I really miss being able to buy Actifed. pseudoephedrine hydrochloride 60 mg as the nasal decongestant and triprolidine hydrochloride 2.5 mg as the antihistamine


Nothing compares IMO.

 

[disneysteve]

Both the DW and I really miss being able to buy Actifed. pseudoephedrine hydrochloride 60 mg as the nasal decongestant and triprolidine hydrochloride 2.5 mg as the antihistamine


Nothing compares IMO.

You can still buy triprolidine. Not sure if you can get it with Sudafed but you can just take them separately.

 

[Sunset]

While they are at it, they should change the name of Pseudoephedrine to Realephedrine

 

[disneysteve]

While they are at it, they should change the name of Pseudoephedrine to Realephedrine

Well if they do that, they’ll also need to change the name of ephedrine which is another medication. Chemically very similar but not identical.

 

[badatmath]

Yeah, this is not news. I always used to get the real stuff.

 

[pacergal]

I tried it and it never worked for me, either.
Actifed was always my go to, worked very well.

 

[bjorn2bwild]

Before it was banned, I used to take the real thing for those long endurance days on the road or trail -
Ephedra as Chinese Ephedra sinensis; Ephedra sinica or 'Ma huang' as it was known - related to the American plant, Mormon Tea. Worked great.
The only side effect I suffered was difficulty sleeping some nights, the same as with Sudafed.

 

[ncbill]

Tossed the Sudafed PE yesterday.

But my doctor has banned me from the 'real' Sudafed since the last time I was in his office after taking such my blood pressure was through the roof.

Which is the one that advertises it won't raise your blood pressure?

 

[disneysteve]

Tossed the Sudafed PE yesterday.

But my doctor has banned me from the 'real' Sudafed since the last time I was in his office after taking such my blood pressure was through the roof.

Which is the one that advertises it won't raise your blood pressure?

Any decongestant can raise your blood pressure. A good alternative is a nasal steroid spray like Nasacort or Flonase.

 

[Aerides]

I swear by Mucinex. It's mainly for cough, but clears up everything for me just enough to feel human. Could be placebo, but it's obvious to me when it wears off and is time for another dose.

 

[disneysteve]

I swear by Mucinex. It's mainly for cough, but clears up everything for me just enough to feel human. Could be placebo, but it's obvious to me when it wears off and is time for another dose.

Mucinex makes numerous products so it’s always important to choose the one that best matches your symptoms.

This is a big pet peeve of mine. If you’re going to make multiple products with different ingredients, don’t give them all the same name. Claritin pills, Claritin nasal spray, and Claritin eye drops are 3 entirely different drugs, for example. When a patient comes in and tells me they’re taking Mucinex, that’s of limited use to me because they rarely know which version they’re taking so I have no way to know what they’ve actually tried.

 

[harley]

Tossed the Sudafed PE yesterday.

But my doctor has banned me from the 'real' Sudafed since the last time I was in his office after taking such my blood pressure was through the roof.

Which is the one that advertises it won't raise your blood pressure?

That would be Mucinex, or any of the other ones that don't work. I'm in the high BP group too, so I'm supposed to avoid the good stuff. Since nothing else really works, I end up just toughing it out.

 

[Texas Proud]

I bought the Sudafed PE maybe once. Never again.

Agree, never worked.

Same here... once and done... always buy the behind the counter stuff that does work...


I also use a spray (Flonase generic IIRC) that works...

 

[JoeWras]

These days I tough it out. Let the body do its thing. I occasionally used real Sudafed back in the day. It worked. Wish I had it for covid. My nose was a firehose.

If I cough, I like Fisherman's friend. I swear it helped for my nighttime covid cough, even though it is just a bunch of herbs mixed with menthol.

 

[harley]

I still stick with the old whiskey/honey/lemon cure.

 

[Koolau]

I still stick with the old whiskey/honey/lemon cure.

Nyquil w*rks for me - at least it lets me sleep. I probably use it once a year.


The nasal spray (steroid) w*rks for routine sinus/allergy symptoms. It's been around in one form or another for 50 years, so reasonably safe and well tested. YMMV