Well-liked nasal decongestant does not relieve congestion, FDA advisers say : NPR

A panel of advisers to the FDA concluded {that a} frequent ingredient in chilly and allergy remedy does not really work. That might lead the company to tug these merchandise from retailer cabinets.


A key ingredient present in dozens of chilly and allergy medicines shouldn’t be efficient. Now, that is the conclusion of a panel of FDA advisers that met yesterday. This might have an effect on lots of the best-known over-the-counter manufacturers, together with Sudafed, Benadryl and NyQuil. NPR’s Allison Aubrey joins us now. Allison, so what’s this ingredient in query?

ALLISON AUBREY, BYLINE: Good morning, A. Effectively, the ingredient known as phenylephrine. And really, the concept phenylephrine, when taken orally, does not work shouldn’t be new. Going again to 2015, there was a citizen’s petition to take away phenylephrine from the over-the-counter medicine within the U.S. Again then, researchers had research displaying that as an oral decongestant, it is utterly ineffective. I spoke to a scientist who’s been behind this effort for years, Leslie Hendeles of the College of Florida Faculty of Pharmacy. He defined to me that phenylephrine will get inactivated by enzymes within the intestine. Lower than 1% of what you swallow really will get into the blood, so it by no means reaches your nostril.

LESLIE HENDELES: In case your drawback is a stuffy nostril and you are taking drugs that has phenylephrine, you’ll nonetheless have a stuffy nostril. That is what the science exhibits. It does not work any higher than a placebo, so that you’re losing your cash.

AUBREY: He says it is usually secure as a result of it doesn’t get absorbed, however typically it is formulated together with different merchandise like Tylenol. In case you have a stuffy nostril, you need one thing to alleviate that. You could not want or need a fever reducer. So backside line – it is not efficient. And there was unanimous settlement among the many FDA advisers who voted yesterday.

MARTÍNEZ: My dad has been in settlement for years.


MARTÍNEZ: He’s so vindicated by this.

AUBREY: He figured this out.

MARTÍNEZ: Yeah. Yeah. So – OK, so how is it then {that a} utterly ineffective ingredient ended up in all of those medicines, over-the-counter medicines?

AUBREY: Effectively, there is a actually fascinating historical past. Again within the early 2000s, laws was handed geared toward combating methamphetamine use. Professor Randy Hatton, additionally of the Faculty of Pharmacy on the College of Florida, informed me that the passage of that legislation, A, pushed many merchandise with pseudoephedrine, which will be processed into meth, behind the counter. And so with the intention to keep gross sales, he says, the over-the-counter medicines had been reformulated inside phenylephrine, which scientists now know to be an ineffective ingredient.

RANDY HATTON: I began getting a rash of calls, like, saying, does oral phenylephrine work? Or what’s the proper dose of oral fentanyl ‘trigger individuals are complaining that the merchandise they used to make use of that had pseudoephedrine in them not work?

AUBREY: And that is what despatched him and Leslie Hendeles off on this lengthy journey to unravel this.

MARTÍNEZ: All proper, so then what occurs now? I imply, can these advisers inform the company what to do?

AUBREY: Effectively, the FDA shouldn’t be obligated to observe the suggestions of an advisory committee, however I spoke to Dr. Caleb Alexander of Johns Hopkins College. He is an internist and an epidemiologist. He says there’s not any scientific controversy right here.

CALEB ALEXANDER: You’ve got an advisory committee that is supplied a unanimous advice, and you’ve got a number of rigorous, well-controlled scientific research that present that this product actually is not any higher than a sugar capsule. And it is in no person’s curiosity to have a product that does not work available on the market.

AUBREY: So now the company may pressure producers to take away these merchandise from the market. And Dr. Alexander says if that occurs, it could upset the markets. There’s practically $2 billion in annual gross sales of those over-the-counter medicines. However he says the markets would regulate, and the excellent news is that there are different over-the-counter medicines which can be efficient as nasal decongestants, together with nasal sprays, so folks would have various choices, A.

MARTÍNEZ: All proper. At the least there’s that. NPR’s Allison Aubrey, thanks rather a lot.

AUBREY: Thanks.


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