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News: FDA panel says common over-the-counter decongestant doesn’t work (Phenylephrine)


Arcadia
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FDA link (89 pages) FDA Briefing Document Efficacy of Oral Phenylephrine as a Nasal Decongestant https://www.fda.gov/media/171915/download
https://www.nbcnews.com/news/amp/rcna104424

”A key ingredient in many over-the-counter cold and allergy medications called phenylephrine doesn’t work to get rid of nasal congestion, a Food and Drug Administration advisory panel concluded Tuesday. 

The unanimous vote, which specifically declared oral formulations of phenylephrine ineffective, is expected to disrupt the market for OTC cold and allergy remedies, where consumers largely prefer pills over nasal sprays.

Phenylephrine — found in drugs including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion — is the most popular oral decongestant in the United States, generating almost $1.8 billion in sales last year, according to data presented Monday by FDA officials. 

The drug is thought to relieve congestionby reducing the swelling of blood vessels in the nasal passages.

The panel’s vote reflects damning evidence provided by the FDA that found that when phenylephrine is taken orally, a very small amount of the drug actually reaches the nose to relieve congestion.

Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy in North Carolina and an advisory committee member, said the evidence is "pretty compelling that this medication is not effective. I don’t think additional data are needed to support that conclusion." 

The FDA will now need to decide whether to revoke the drug’s OTC designation as “generally recognized as safe and effective.” The designation, typically used for older drugs, allows drugmakers to include an ingredient in OTC products without the need to file an FDA application.

Without the designation, products containing the ingredient may need to be removed from store shelves, or manufacturers may have to develop new formulations. A spokesperson for the FDA declined to say when the agency will make a final decision. The FDA usually sides with its advisory committees.

Phenylephrine gained popularity in the early 2000s as a replacement for pseudoephedrine, the decongestant used in Sudafed, which was moved behind the pharmacy counter in 2006 in an attempt to curb its misuse as an ingredient to make methamphetamine. 

During the two-day meeting, FDA scientists presented the results of five studies conducted over the past two decades on the effectiveness of oral phenylephrine. All the studies concluded that the decongestant was no more effective than a placebo.

They also re-evaluated the initial findings used to support its OTC use. The agency found that the results were inconsistent, did not meet modern standards for study design and may have had data integrity issues.

“In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant,” said Dr. Peter Starke, an FDA official who led the review of phenylephrine. 

The concern goes beyond ineffectiveness; phenylephrine can come with side effects such as headaches, insomnia and nervousness. At higher doses, it can increase blood pressure. 

The panel is not questioning the effectiveness of nasal spray phenylephrine, which is still thought to provide temporary relief from congestion.

Representatives for the Consumer Healthcare Products Association, a group that represents OTC drug manufacturers, did not offer any new evidence to counter the FDA’s claims that the drug is ineffective during their presentation Monday. 

The group instead said that if oral phenylephrine were not available over the counter, it would be a significant burden to consumers.”

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I’ve never really felt like it worked very well.  It was better than nothing, but just barely.  


 

rant/

Sudafed is just so dang hard to get in my state.  It’s not just behind the counter.  Many pharmacies don’t sell it any more, period, they simply don’t stock it at all.   I was told it wasn’t worth the hassle after the law changed.  The bigger pharmacies like CVS or Walgreens will only sell it to you if you have at least one monthly prescription with them. Meaning my husband could  buy it but not me because I’m not on any prescriptions.  It’s so frustrating to get a cold and have no accessible, effective medication.  So many times a cold or allergies has turned into bronchitis or a sinus infection because I wasn’t able to dry it out with anything, then I need prescription decongestions, steroids and antibiotics, plus a $150 office visit where a few days of Sudafed would have been sufficient.  
/end rant 

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@Heartstrings Benadryl works for me for hay fever because of the antihistamine (diphenhydramine). Albuterol (salbutamol) tablets also work well but I think that might need a prescription. Could your husband buy the Sudafed behind the counter for you when he next get his prescription? They have long expiration dates so buying a box for emergency use is not too bad. 

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In my state, a rx for sudafed gets me more tablets than my state law allowed me to have.

I agree, phenylephrine is worthless.

Also, can we talk about how nonsensical some of this is? With all of the cheap fentanyl on the streets and the like, are we really going to quibble over 24 Sudafed tablets? If people want a cheap and effective high, there are plenty of opportunities outside of having to play kitchen yourself like in Breaking Bad.

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1 hour ago, Heartstrings said:

I’ve never really felt like it worked very well.  It was better than nothing, but just barely.  


 

rant/

Sudafed is just so dang hard to get in my state.  It’s not just behind the counter.  Many pharmacies don’t sell it any more, period, they simply don’t stock it at all.   I was told it wasn’t worth the hassle after the law changed.  The bigger pharmacies like CVS or Walgreens will only sell it to you if you have at least one monthly prescription with them. Meaning my husband could  buy it but not me because I’m not on any prescriptions.  It’s so frustrating to get a cold and have no accessible, effective medication.  So many times a cold or allergies has turned into bronchitis or a sinus infection because I wasn’t able to dry it out with anything, then I need prescription decongestions, steroids and antibiotics, plus a $150 office visit where a few days of Sudafed would have been sufficient.  
/end rant 

It’s not quite as hard to get here, but it’s like it’s frowned upon. We made quite the splash buying it for our one of our kids when he was little too—he needed to be able to breathe when they had colds (and we now know that one has a serious condition that makes it hard to clear mucus and is aggravated by drainage, but no one noticed back then).

Politics over effectiveness never sits well with me.

Do they still limit how much baby formula you can buy because of meth too?

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I’m sure this is different in every state, but just in case anyone needs to hear this, Costco is the easiest/best place I’ve ever gotten Sudafed (pseudoephedrine) from behind the counter. 1) it was the cheapest and 2) the checkout person seemed surprised that I only wanted one box and not the maximum allowed. So yeah, good place to buy for sure. 

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21 minutes ago, mmasc said:

I’m sure this is different in every state, but just in case anyone needs to hear this, Costco is the easiest/best place I’ve ever gotten Sudafed (pseudoephedrine) from behind the counter. 1) it was the cheapest and 2) the checkout person seemed surprised that I only wanted one box and not the maximum allowed. So yeah, good place to buy for sure. 

Good to know, thanks! We don’t need it often, but when we do, there’s just nothing else that works as well. It’s gotten so $$$$$ though! I’ll have to check prices at our Costco when we go next. 

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14 minutes ago, Grace Hopper said:

Good to know, thanks! We don’t need it often, but when we do, there’s just nothing else that works as well. It’s gotten so $$$$$ though! I’ll have to check prices at our Costco when we go next. 

I should add that I bought the generic pseudoephedrine, not brand name Sudafed. Same thing. But very affordable at Costco!

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12 minutes ago, mmasc said:

I should add that I bought the generic pseudoephedrine, not brand name Sudafed. Same thing. But very affordable at Costco!

We also get the generic at our local grocery store.  Much more affordable.  I wonder if they are going to sell out quickly now with this news.  

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1 hour ago, Terabith said:

I'm shocked.  Shocked, I tell you.  

It really irritates me that I have more limitations about buying sudafed (especially if multiple people in the house have a cold at the same time) than I do about filling prescriptions for benzos or opioids.  

IKR??? All the times we’ve needed hydrocodone following various procedures and we easily get a full vial for a copay of five bucks and don’t have to even show ID to pick them up? Then for the real pseudoephedrine they want my ID, my fingerprints, a week’s wages for one small box that will get just one person through a sinus infection… upside down, I tell ya. 😂

Edited by Grace Hopper
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7 hours ago, Arcadia said:

@Heartstrings Benadryl works for me for hay fever because of the antihistamine (diphenhydramine). Albuterol (salbutamol) tablets also work well but I think that might need a prescription. Could your husband buy the Sudafed behind the counter for you when he next get his prescription? They have long expiration dates so buying a box for emergency use is not too bad. 

I haven't tried in awhile. We switched to a pharmacy that doesn't sell them so I've been trying to get through with mucinex.  

 

Does any know if all of this locking away of the Sudafed has actually done anything to reduce meth?  I don't really feel like it has but my googling isn't giving me much.   

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yeah, we all know none of it works anymore.  We buy the 30mg over the counter and hand over our I.D....or buy the 10mg and swallow3-6 at a time! Also the cold medicines don't work anymore, you have to take it all separately now...a sudafed, bendedril and pain reliever all separate.  It is so infuriating. 😞  We used to reserve niquil for the baddest colds at bedtime, but now it's a waste of money. 

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6 hours ago, wisdomandtreasures said:

 

Well knock me over with a feather

 

Love the meme, but you should delete it. Our wonderful host has previously been sued over celebrity photos being posted on this board. I think there’s still a pinned post explaining what happened. She’s asked us not to post anything with celebrity photographs. 

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4 hours ago, Terabith said:

I'm shocked.  Shocked, I tell you.  

It really irritates me that I have more limitations about buying sudafed (especially if multiple people in the house have a cold at the same time) than I do about filling prescriptions for benzos or opioids.  

 

3 hours ago, Grace Hopper said:

IKR??? All the times we’ve needed hydrocodone following various procedures and we easily get a full vial for a copay of five bucks and don’t have to even show ID to pick them up? Then for the real pseudoephedrine they want my ID, my fingerprints, a week’s wages for one small box that will get just one person through a sinus infection… upside down, I tell ya. 😂

Good point.  I didn't think about that.  

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11 hours ago, Heartstrings said:

I’ve never really felt like it worked very well.  It was better than nothing, but just barely.  


 

rant/

Sudafed is just so dang hard to get in my state.  It’s not just behind the counter.  Many pharmacies don’t sell it any more, period, they simply don’t stock it at all.   I was told it wasn’t worth the hassle after the law changed.  The bigger pharmacies like CVS or Walgreens will only sell it to you if you have at least one monthly prescription with them. Meaning my husband could  buy it but not me because I’m not on any prescriptions.  It’s so frustrating to get a cold and have no accessible, effective medication.  So many times a cold or allergies has turned into bronchitis or a sinus infection because I wasn’t able to dry it out with anything, then I need prescription decongestions, steroids and antibiotics, plus a $150 office visit where a few days of Sudafed would have been sufficient.  
/end rant 

This doesn’t make sense to me. It’s  still an OTC drug. If you want to use one of those pharmacies, your husband can buy it and you can take it. The purchase limits are actually quite high. I know a family with five kids and they have never hit the limit. It’s not a big deal.

That requirement at CVS must be state specific or regional or something. They don’t even pull up our records when we buy it. 

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13 hours ago, Grace Hopper said:

Good to know, thanks! We don’t need it often, but when we do, there’s just nothing else that works as well. It’s gotten so $$$$$ though! I’ll have to check prices at our Costco when we go next. 

I'll keep that in mind. I don't need it often. Usually my symptoms are hay fever type controlled by generic Zyrtec, or if it's really bad then I take generic Benadryl. Our insurance pays for $60 per quarter for OTC meds through a health Visa card. Costco isn't on the list where we can use the card but if I use up my $60 and need sudafed before the new quarter I'll go to Costco.

9 hours ago, Grace Hopper said:

IKR??? All the times we’ve needed hydrocodone following various procedures and we easily get a full vial for a copay of five bucks and don’t have to even show ID to pick them up? Then for the real pseudoephedrine they want my ID, my fingerprints, a week’s wages for one small box that will get just one person through a sinus infection… upside down, I tell ya. 😂

Huh. We definitely have to show ID here. The few times one of us had a procedure requiring oxycodone we had to show ID regardless of who picked up the rx. Also, when I was taking it for chronic back pain before my surgery I had to see the doctor monthly and randomly pee in a cup. It could be different in different states. Florida became an oxy pill mill state at one point so our regs probably were made more strict as a result.

Edited by Lady Florida.
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6 hours ago, TechWife said:

This doesn’t make sense to me. It’s  still an OTC drug. If you want to use one of those pharmacies, your husband can buy it and you can take it. The purchase limits are actually quite high. I know a family with five kids and they have never hit the limit. It’s not a big deal.

That requirement at CVS must be state specific or regional or something. They don’t even pull up our records when we buy it. 

It’s state specific.  We’re much tighter than any other state I’ve heard of, or lived in.  

We don’t have prescriptions with CVS or Walgreens anymore because they are much more expensive for us, so we’ve moved to a smaller pharmacy that chose to simply stop selling Sudafed instead of dealing with the law.  So even though it’s technically over the counter medication I’m not able to access it easily.  Or at all to my knowledge.  


They are strict on the purchase limit here too.  When we did use CVS they would sell  us exactly 10 pills every 10 days, which is a 5 day supply of 12 hours pills.  Per person with an active prescription.   You have a 5 person household, but only 1 prescription holder?  You get 10 pills, good luck, hope you thought to stockpile it.  Your doctor wrote you a 30 prescription?  You can pick up 10 pills 3 times, per prescription.  If they keep track of it we’ll enough, which they usually don’t meaning you still only get the first 10 pills most of the time. 

I know it’s technically over the counter but in my state its functionally a tightly controlled prescription that can only be filled at certain pharmacies.  It’s way easier to get addictive pain medication.  
 

I have to imagine that the stock piling that is required to have Sudafed when you need it actually makes it worse for meth.  Grandpa starts stockpiling it for easy access during cold season, then his tweaker grandson can steal a 2 month supply from the medicine cabinet at once.   

Edited by Heartstrings
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1 hour ago, Lady Florida. said:

it's really bad then I take generic Benadryl.

I’ve seen a lot of stuff lately saying Benadryl is no longer recommended. It can cross the blood brain barrier and has shown a connection with dementia. They recommend taking newer allergy medications instead.   Of course I started seeing that information after I accidentally ended up with 4,bottles of Benadryl.  🙄

 

https://beta.ctvnews.ca/national/health/2022/4/3/1_5846518.amp.html

 

 

https://www.health.harvard.edu/blog/common-anticholinergic-drugs-like-benadryl-linked-increased-dementia-risk-201501287667

 

 

Edited by Heartstrings
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53 minutes ago, Heartstrings said:

I’ve seen a lot of stuff lately saying Benadryl is no longer recommended. It can cross the blood brain barrier and has shown a connection with dementia. They recommend taking newer allergy medications instead.   Of course I started seeing that information after I accidentally ended up with 4,bottles of Benadryl.  🙄

 

https://beta.ctvnews.ca/national/health/2022/4/3/1_5846518.amp.html

 

 

https://www.health.harvard.edu/blog/common-anticholinergic-drugs-like-benadryl-linked-increased-dementia-risk-201501287667

 

 

Newer allergy medicines that could turn out to have similar problems in the future? Is there any reason to think these different allergy medicines actually do not have the same problem?

Because Benadryl is a two purpose drug in our house -- not just cat allergies, etc. But stopping rashes/more active allergies (we are not at the stage of needing an epi pen. But I don't know of any other OTC drug that does this)

 

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24 minutes ago, vonfirmath said:

Newer allergy medicines that could turn out to have similar problems in the future? Is there any reason to think these different allergy medicines actually do not have the same problem?

It seems to me that it's pretty obvious whether an allergy medicine works or not.  I've heard for years that the new Sudafed didn't work.  What's weird is that if this particular med didn't work, why do people continue to buy it?  Of course, I never found the old Sudafed to be helpful either.  I was more of an Actifed person (which also contains an antihistamine).

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19 hours ago, prairiewindmomma said:

In my state, a rx for sudafed gets me more tablets than my state law allowed me to have.

I agree, phenylephrine is worthless.

Also, can we talk about how nonsensical some of this is? With all of the cheap fentanyl on the streets and the like, are we really going to quibble over 24 Sudafed tablets? If people want a cheap and effective high, there are plenty of opportunities outside of having to play kitchen yourself like in Breaking Bad.

Yup. I grumble every single time. Like, trust me, this is Florida - we are more likely to turn meth back into sudafed given how bad allergies are here!

3 minutes ago, EKS said:

It seems to me that it's pretty obvious whether an allergy medicine works or not.  I've heard for years that the new Sudafed didn't work.  What's weird is that if this particular med didn't work, why do people continue to buy it?  Of course, I never found the old Sudafed to be helpful either.  I was more of an Actifed person (which also contains an antihistamine).

I'm pretty sure low dose Claritin doesn't do much either, actually. I even had an ENT tell me that (which matched my experience). He said the original prescription stuff worked, but made people drowsy. They REALLY wanted to make a product they could market as non drowsy, but to do that had to drop the dose so much that it really doesn't do much of anything. Again, matched my experience. I know a few people that use it and say it helps but I wonder it if is just placebo? Or if it helps, but not much? 

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Here store to store it varies how much I can get. Some stores will sell one box or bottle, period. Others will let me get up to the mg limit, even if it is two packages. The issue is that if we have both adults and kids sick and need both - I can get a small box of the 4 hour kind plus a bottle of the liquid, at some places, but can't get a box of the 12 hour kind for adults and the bottle of kid's liquid as that puts me over the limit. Such a PIA to deal with when the whole house is sick! 

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What I don't like about the Sudafed behind the counter (pseudoephedrine) is that I can't take it after noon because it acts like a stimulant for me and I can't sleep.  I'm lucky that I rarely get sick but I liked the idea of the phenylephrine because I could take it anytime without worrying about that effect.  I wish there was something effective without side effects.  

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9 minutes ago, ktgrok said:

They REALLY wanted to make a product they could market as non drowsy, but to do that had to drop the dose so much that it really doesn't do much of anything.

That seems like an easy fix--just take the amount in the prescription strength version.  Of course then you get back to drowsy.  I actually found that the OTC version made me drowsy the one time I took it.  

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1 hour ago, vonfirmath said:

Newer allergy medicines that could turn out to have similar problems in the future? Is there any reason to think these different allergy medicines actually do not have the same problem?

Because Benadryl is a two purpose drug in our house -- not just cat allergies, etc. But stopping rashes/more active allergies (we are not at the stage of needing an epi pen. But I don't know of any other OTC drug that does this)

 

From what I’ve read the newer meds at least don’t cross the blood brain barrier and of course don’t cause the drowsiness.    That’s enough for me, personally.  My mom took Benadryl nearly daily and ended up with dementia at 58 or so.   That doesn’t mean she got it from Benadryl of course, but I’m pretty particular about medication now.  Benadryl has been shown to have that connection, so I’ve stopped using it.  If new medication shows that connection I’ll stop using that too.  I’m not going to keep using a medication that has shown that connection on the chance that the newer meds will also.  Of course that’s just me, trying to reduce my own dementia risk.   Anyone can make different decisions, but since the information isn’t widely known I decided to share it.  
 

What I have seen is the recommendation for using Zyrtec or Allegra in place of Benadryl even for allergic reactions because they work faster and longer.  So that’s the recommendation for rashes and allergic exposure.  I tracked that down because I have family that carry epi pens.  They still choose Benadryl, but I at least let them know the new recommendations.  

Edited by Heartstrings
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28 minutes ago, ktgrok said:

Yup. I grumble every single time. Like, trust me, this is Florida - we are more likely to turn meth back into sudafed given how bad allergies are here!

I'm pretty sure low dose Claritin doesn't do much either, actually. I even had an ENT tell me that (which matched my experience). He said the original prescription stuff worked, but made people drowsy. They REALLY wanted to make a product they could market as non drowsy, but to do that had to drop the dose so much that it really doesn't do much of anything. Again, matched my experience. I know a few people that use it and say it helps but I wonder it if is just placebo? Or if it helps, but not much? 

I figured I had just gotten immune to Claritin.  I’m using xyzal (sp?) right now and it works decently.  

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2 hours ago, Heartstrings said:

From what I’ve read the newer meds at least don’t cross the blood brain barrier and of course don’t cause the drowsiness.    That’s enough for me, personally.  My mom took Benadryl nearly daily and ended up with dementia at 58 or so.   That doesn’t mean she got it from Benadryl of course, but I’m pretty particular about medication now.  Benadryl has been shown to have that connection, so I’ve stopped using it.  If new medication shows that connection I’ll stop using that too.  I’m not going to keep using a medication that has shown that connection on the chance that the newer meds will also.  Of course that’s just me, trying to reduce my own dementia risk.   Anyone can make different decisions, but since the information isn’t widely known I decided to share it.  
 

What I have seen is the recommendation for using Zyrtec or Allegra in place of Benadryl even for allergic reactions because they work faster and longer.  So that’s the recommendation for rashes and allergic exposure.  I tracked that down because I have family that carry epi pens.  They still choose Benadryl, but I at least let them know the new recommendations.  

Sadly Zyrtec causes drowsiness for me, to the point I can't use it anymore. But, I'm now taking singulair which is awesome for me. If I need more than that I take allegra. 

I do still take benedryl when I have insomnia, but it is a few times a month at most, and usually half dosage.

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1 hour ago, ktgrok said:

Sadly Zyrtec causes drowsiness for me, to the point I can't use it anymore. But, I'm now taking singulair which is awesome for me. If I need more than that I take allegra. 

I do still take benedryl when I have insomnia, but it is a few times a month at most, and usually half dosage.

Me too, Zyrtec knocks me out!

To be fair, though, I’ve never met an antihistamine that didn’t make me sleepy. Allegra, Benadryl and xyzal…. can’t hold my eyes open. 

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1 hour ago, ktgrok said:

 

I do still take benedryl when I have insomnia, but it is a few times a month at most, and usually half dosage.

One of my family doctors advised me years ago to take 1/2 dose every night to help me sleep because of my carpal tunnel syndrome keeping me up.  I'm glad I didn't follow his recommendation.

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7 hours ago, Heartstrings said:

I’ve seen a lot of stuff lately saying Benadryl is no longer recommended. It can cross the blood brain barrier and has shown a connection with dementia. They recommend taking newer allergy medications instead.   Of course I started seeing that information after I accidentally ended up with 4,bottles of Benadryl.  🙄

The studies (mostly one from 2015) discuss long term and frequent use of anticholinergic medications, including meds for overactive bladder or incontinence not just allergy drugs. I take Benadryl on those days when I can't stop sneezing and my eyes itch so badly I want to scratch them out. I don't take it regularly and never more than one dose on the days I take it. Mostly I just take Zyrtec daily. It doesn't make me drowsy. Claritin and Allegra are useless for me. I recently started allergy shots and sometimes my reaction at the injection site is so uncomfortable that oral Benadryl is the only thing that calms it down (yes, they diluted that particular vial but I still get a reaction). Topical anti-itch creams don't do anything for it.

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