FDA rules TODAY that ingredient in Benadryl and Sudafed from pharmacy shelves don't work

[Sly Saint]

A Food and Drug Administration panel today unanimously ruled that a medicine used by millions for a stuffy nose does not work.

Phenylephrine is the most common active compound in over-the-counter drugs like Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night.

But an FDA panel said after a two-day review that the oral decongestant ‘is not effective’ at standard or even high doses.

Their ruling is not binding but it strongly suggests that the agency could soon heed their advice and pull its approval, which would force companies to pull or reformulate their products.

The ingredient is protected under the FDA’s Generally Recognized as Safe and Effective (GRASE) designation, but a reversal of its approval could mean manufacturers including Bayer and Johnson and Johnson might need to reformulate.

Phenylephrine is everywhere, so much so that nearly every nasal decongestant on pharmacy shelves contains it.

Drugs that contain it generated almost $ 1.8 billion in sales last year, according to data presented Monday by FDA officials.

A unanimous vote by the 16-member Nonprescription Drug Advisory panel could issue a major blow to the industry.

Today's ruling only applies to oral formulations of phenylephrine, which account for about one-fifth of the $2.2 billion market for oral decongestants.

FDA rules TODAY that ingredient in Benadryl and Sudafed from pharmacy shelves don't work | Daily Mail Online

 

[Jaybee00]

Merged thread

Popular OTC medicines for colds and allergies don’t work, FDA panel says

https://www.cnn.com/2023/09/12/health/phenylephrine-tablets-ineffective-fda-panel-says/index.html


Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medicines, is ineffective in tablet form, an independent advisory committee to the US Food and Drug Administration agreed Tuesday.

 

[Ash]

I prefer pseudoephedrine for that. It works head pressure lifts, aches and pains vanished. But then a bit later feel like I’m having a heart attack. So…

 

[ukxmrv]

That's the ingredient that changed in Sudafed. It gave me palpitations and did nothing for my sinus problems. I still seek out the older type with pseudopephidrine

 

[Ash]

That's the ingredient that changed in Sudafed. It gave me palpitations and did nothing for my sinus problems. I still seek out the older type with pseudopephidrine

Yeah, I remember telling the pharmacist that these decongestants used to work for me but now didn’t and they said “you want the good stuff which you have to ask us for.” The packaging was virtually identical so many were caught out. Then this pharmacy gave me a massive quiz about my health and eventually handed it over. I’ve used only rarely because you can become dependent on it and experience rebound sinus pain and then there’s nothing left to do. So it’s my last resort. But I used to be fine with it, COVID caused heart issues and scuppered this for me.

Also Sudafed has quite a monopoly, it’s quite difficult to get the own brand versions which can be about half the cost for the same product.