Popular nasal decongestant doesn't relieve congestion, FDA advisers say
A MARTÍNEZ, HOST:
A key ingredient found in dozens of cold and allergy medicines is not effective. Now, that's the conclusion of a panel of FDA advisers that met yesterday. This could affect many of the best-known over-the-counter brands, including Sudafed, Benadryl and NyQuil. NPR's Allison Aubrey joins us now. Allison, so what's this ingredient in question?
ALLISON AUBREY, BYLINE: Good morning, A. Well, the ingredient is called phenylephrine. And actually, the idea that phenylephrine, when taken orally, doesn't work is not new. Going back to 2015, there was a citizen's petition to remove phenylephrine from the over-the-counter drugs in the U.S. Back then, researchers had studies showing that as an oral decongestant, it's completely ineffective. I spoke to a scientist who's been behind this effort for years, Leslie Hendeles of the University of Florida College of Pharmacy. He explained to me that phenylephrine gets inactivated by enzymes in the gut. Less than 1% of what you swallow actually gets into the blood, so it never reaches your nose.
LESLIE HENDELES: If your problem is a stuffy nose and you take medicine that has phenylephrine, you will still have a stuffy nose. That's what the science shows. It doesn't work any better than a placebo, so you're wasting your money.
AUBREY: He says it's generally safe because it does not get absorbed, but sometimes it's formulated in combination with other products like Tylenol. If you have a stuffy nose, you want something to relieve that. You may not need or want a fever reducer. So bottom line - it's not effective. And there was unanimous agreement among the FDA advisers who voted yesterday.
MARTÍNEZ: My dad has been in agreement for years.
MARTÍNEZ: He is so vindicated by this.
AUBREY: He figured this out.
MARTÍNEZ: Yeah. Yeah. So - OK, so how is it then that a completely ineffective ingredient ended up in all of these medicines, over-the-counter medicines?
AUBREY: Well, there's a really interesting history. Back in the early 2000s, legislation was passed aimed at combating methamphetamine use. Professor Randy Hatton, also of the College of Pharmacy at the University of Florida, told me that the passage of that law, A, pushed many products with pseudoephedrine, which can be processed into meth, behind the counter. And so in order to maintain sales, he says, the over-the-counter medicines were reformulated within phenylephrine, which scientists now know to be an ineffective ingredient.
RANDY HATTON: I started getting a rash of calls, like, saying, does oral phenylephrine work? Or what is the right dose of oral fentanyl 'cause people are complaining that the products they used to use that had pseudoephedrine in them no longer work?
AUBREY: And that's what sent him and Leslie Hendeles off on this long journey to get to the bottom of this.
MARTÍNEZ: All right, so then what happens now? I mean, can these advisers tell the agency what to do?
AUBREY: Well, the FDA is not obligated to follow the recommendations of an advisory committee, but I spoke to Dr. Caleb Alexander of Johns Hopkins University. He's an internist and an epidemiologist. He says there's not any scientific controversy here.
CALEB ALEXANDER: You have an advisory committee that's provided a unanimous recommendation, and you have multiple rigorous, well-controlled scientific studies that show that this product really is no better than a sugar pill. And it's in nobody's interest to have a product that doesn't work on the market.
AUBREY: So now the agency could force manufacturers to remove these products from the market. And Dr. Alexander says if that happens, it would upset the markets. There's nearly $2 billion in annual sales of these over-the-counter medicines. But he says the markets would adjust, and the good news is that there are other over-the-counter medicines that are effective as nasal decongestants, including nasal sprays, so people would have alternative options, A.
MARTÍNEZ: All right. At least there's that. NPR's Allison Aubrey, thanks a lot.
AUBREY: Thank you.
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