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A common ingredient in over-the-counter decongestants does not work, experts say

AILSA CHANG, HOST:

And now some news for anyone out there who has ever wandered down the medicine aisle looking for something to clear up their stuffy nose. Turns out a key ingredient in many popular over-the-counter decongestants does not work. That was the conclusion of a panel of experts who advised the Food and Drug Administration who met yesterday. NPR's Will Stone joins us now to explain what is going on. Hey, Will.

WILL STONE, BYLINE: Hi, Ailsa.

CHANG: OK, so set the stage for us here. What exactly is this drug?

STONE: Yeah, it's a bit of a mouthful. It's called phenylephrine, and you'll see it abbreviated as PE on packaging. It's found in many popular cold and allergy decongestants that are taken by mouth and sold over the counter. And basically, these FDA advisers reviewed all the evidence, especially the more recent studies, and they concluded that it's not effective, at least when taken orally. And they were so convinced, it was actually a unanimous recommendation.

CHANG: Unanimous. OK, so what does this practically mean for these drugs?

STONE: Well, the FDA does not have to follow the recommendations of its advisers. Given the strength of the evidence, the expectation of many experts, including Randy Hatton who's at the University of Florida, is that they will agree with the assessment that it's ineffective.

RANDY HATTON: Which would eventually lead to these products being removed from the market. Now, there are many products that can contain this. I mean, it would clearly change the appearance of the cough and cold and allergy aisles at your local pharmacy.

CHANG: Unbelievable.

STONE: And Hatton is actually very close to this fight over phenylephrine. He started looking into whether this worked around 20 years ago and was one of the researchers who asked the FDA to look into it. And the science here is basically that when you take phenylephrine orally at this dose, the drug gets broken down and doesn't end up actually helping your nose.

CHANG: (Laughter).

STONE: Despite this, though, these products were responsible for almost $2 billion in sales just last year alone.

CHANG: I mean, that is remarkable, Will. How did this ineffective drug ever end up on shelves in the first place?

STONE: Yeah. It turns out that phenylephrine has been around for a long time, and while we know it's safe, it essentially got grandfathered in and went through a different process than what's required for newer drugs that come on the market. Hatton says it was kind of an accident of history because in the early 2000s, legislation was passed to combat methamphetamine use, and that led to pseudoephedrine, which was widely used at the time, moving behind the pharmacy counter. Pseudoephedrine can be used to make meth. So as a result of all of this, phenylephrine replaced it in many of these popular decongestants that are sold over the counter.

Stefanie Ferreri is at the UNC Eshelman School of Pharmacy. She remembers what she was hearing when these products first became popular.

STEFANIE FERRERI: When it first came out, a lot of people were like, this doesn't seem to be working as well. This doesn't seem to be working as well. So as a pharmacist, we heard a lot of anecdotal evidence from our patients saying it was not as effective as the pseudoephedrine, which was also on the market.

STONE: Ferreri says she hopes that this reckoning over phenylephrine prompts the FDA to look at the evidence base for other older over-the-counter drugs. Some of the concern around phenylephrine is that while it's not dangerous, patients have been taking it, and if it's not working, it's essentially leading to delays in care and not actually resolving their symptoms.

CHANG: Exactly. OK, so what are the implications here as we all roll into a new cold season?

STONE: Yeah, well, there are certainly other options for people who need a decongestant. There's pseudoephedrine, which Ferreri just mentioned. It's sold behind the counter. You need to show your ID, but you don't need a prescription for it. I spoke to Dr. Derrick Ward, who's with Kansas City Allergy & Asthma Associates. He says he can't really remember a time in his 17 years of practice when he's recommended phenylephrine.

DERRICK WARD: If I'm going to recommend a decongestant to somebody, I would typically either recommend a short course of a nasal decongestant spray, you know, like a generic Afrin, usually for 3 to 5 days. Maybe if they've got a cold or something like that or sinus infection or an oral - if I'm going to do an oral decongestant, I would almost always recommend we use pseudoephedrine.

STONE: So bottom line, Ailsa, while this news about phenylephrine may create some confusion among consumers, it could upset the market - if it does get pulled, doctors and pharmacists say there are still plenty of good options for consumers.

CHANG: That is NPR's Will Stone. Thank you so much, Will.

STONE: Thank you. Transcript provided by NPR, Copyright NPR.

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Will Stone