FDA proposes pulling Sudafed and Benadryl from pharmacy shelves

Sly Saint

Sly Saint

Senior Member (Voting Rights)
The FDA wants to pull common cold and flu medications from drugstore shelves after studies found the main ingredient was useless in treating the viruses.

The agency proposed on Thursday discontinuing the use of phenylephrine, an ingredient in common medications like Sudafed and Benadryl, because it 'is not effective' in treating or relieving virus symptoms such as nasal congestion.

The key ingredient in a wide variety of over-the-counter oral decongestants has been thought to be ineffective for years and in March 2023, the FDA began reviewing the use of phenylephrine after a meta-analysis found it was no more effective than a placebo.

When metabolized in the gut, phenylephrine can’t reach the bloodstream in sufficient levels, rendering it useless in providing relief.

Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in the agency's notice: 'It is the FDA’s role to ensure that drugs are safe and effective.

'Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.'

This is only a 'proposed order' and will not have an immediate impact on the medications. Only a 'final order' will affect what products are sold.

The FDA added: 'The proposed order is based on effectiveness concerns, not on safety concerns.'
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FDA proposes pulling Sudafed and Benadryl from pharmacy shelves
 
Creekside said:
Phenylephrine was in use in 1938, although the wiki didn't say when it started being marketed for colds. That seriously slow testing of effectiveness makes me leery about all the other FDA-approved drugs on the market.
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I think the problem is that if a drug gets over the counter approval nobody really cares whether it works or not. Most over the counter things you can buy do nothing - supplements, cosmetics, hair tonics ... Testing for drugs on prescription tends to be reliable, even if there are some dubious ones.
 
Denise said:
I don't understand why Benadryl is included here as its main ingredient is NOT phenylephrine (supposedly a decongestant) - it is diphenhydramine HCl (an antihistamine and often used as a sleep aid in the US)
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This link states the product is "Benadryl Allergy Plus Congestion". That product does have 10% Phenylephrine.

I really hope it is not all Benadryl.
 
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Aussie law firm sues pharma giant over bombshell drug claims
Pharmaceutical giant Johnson & Johnson has been hit with bombshell claims the company sold dodgy cold and flu medication to Australians.

Brisbane-based law firm JGA Saddler filed a class action against the multi-billion dollar company on Friday over the allegations.

Millions of Aussies could be eligible for compensation over claims Johnson & Johnson falsely stated several medications it sold relieved congestion.
The class action pertains to tablets in products such as Codral Day and Night and Sudafed PE that contain a substance called phenylephrine.

The US Food and Drug Administration (FDA) last year ruled the drug did not provide effective relief as a nasal decongestant when taken in the form of a tablet.

The class action claims Johnson & Johnson knowingly marketed and sold medications that don't work to Aussies for years.

The advertising on the Johnson & Johnson Codral Day and Night medication states 'Phenylephrine helps to relieve blocked and runny noses'.

A similar advertisement on the packaging of Sudafed PE medication refers to the drug as a 'nasal decongestant'.

The medication's website indicated that the product 'provides fast, powerful relief from sinus pressure and nasal congestion.'

Lawyer and director of JGA Saddler Rebecca Jancauskas said the company misled customers.

'Customers should be able to confidently buy medicines that work as advertised and when they don't, the company involved should be held accountable,' Ms Jancauskas told Nine News.
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Aussie law firm sues pharma giant over bombshell drug claims
 
One big problem with diphenhydramine is that long term use increases the risk of developing dementia.

https://www.health.harvard.edu/blog...l-linked-increased-dementia-risk-201501287667

https://www.scientificamerican.com/article/does-long-term-benadryl-use-increase-dementia-risk/

About 15 years ago I read a post on a forum similar to this one in which the person writing was taking very regular doses of diphenhydramine and had kept it up for months. She found herself struggling to walk, so I knew it wasn't exactly benign.

I did take it for a while myself in normal doses but only when I was desperate to get some sleep. It made me feel awful within a couple of weeks the first time I tried it so I have done my best to completely avoid it.

Regarding sudafed and benadryl being declared "ineffective" in treating viral conditions/symptoms, I do wonder what the researchers were looking for in terms of effectiveness. I am not aware that there are any treatments that truly shorten a cold or flu or any similar viral condition. I do use cold and flu remedies when I think it is appropriate but it isn't because I believe they actually treat such conditions. I find that they are helpful in making me feel a little bit better or mildly more comfortable and they help me get to sleep a bit faster than I would without those products. Whenever I have had something viral I don't really expect anything else from such products but I would be rather dismayed if they were to disappear from sale because I want something to help make me feel more comfortable for a few hours or while I am trying to sleep.
 
Many years ago (20+) I used to use one of the sudafeds to reduce sinus pain - what I was under the impression sudafed was marketed for.

It was, out of everything in the UK that could be purchased over the counter, the only one that worked, for me.

Then, probably about 15 years ago, they changed the active ingredient, without bothering to mention it, and it no longer worked for me, at all.

So, I'm not surprised that the current version is ineffective, for sinus pain.

I am surprised that anyone, in authority, cares, as many, many, many, other OTC meds also do basically squat, or at least don't do what they say, and charge a heavy premium to do, more effectively, they claim, that other products.
 
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