Decongestants

Tens of millions of Americans suffer from nasal and sinus congestion and turn to medicine you can buy on store shelves without a prescription. But it turns out they may be a big waste of money. Because these are not your daddy’s decongestants. The active ingredient has been switched out for one that, by nearly every account, doesn’t work. Today, the inside story.

The first thing to you should know is that decongestants with the same brand name may contain two completely different active ingredients. And by nearly every account— one of them doesn’t work.

Leslie Hendeles: It was no different than taking a placebo for a stuffy nose.

To help tell this story, we turn to Leslie Hendeles, a Doctor of Pharmacy, and professor Emeritus at the University of Florida.

The two ingredients we’re talking about are pseudoephedrine and phenylephrine. Most decongestants before 2006 contained pseudoephedrine, which works. But after 2006, most changed to phenylephrine, which doesn’t work, according to experts.

Hendeles’s role in the scandal began more than 30 years ago after he did research for an article on decongestants.

Hendeles: And in that article, I commented that this phenylephrine was not an effective drug.

America’s switch from the ingredient that worked, to the one that doesn’t, was made around 2007 because the original products were being abused by meth users and drug dealers.

Sharyl: So there was a point in time during which the ingredient that is widely agreed upon works well was being abused by people who make illegal meth or methamphetamines?

Hendeles: Correct. So that’s why the Congress passed a law, the “Combat Methamphetamine Epidemic Act” that requires pseudoephedrine to be behind the counter.

A version of the decongestants remained available on regular store shelves but switched to the allegedly ineffective active ingredient.

Most people probably didn’t know about the switch, but may have noticed their tried-and-true cold medicine no longer worked.

Hendeles: So after, after the law was passed and pharmacists had to move the pseudoephedrine behind the counter, the patients were buying the products that had phenylephrine in it and then complaining to the pharmacist that it didn't work.

The University of Florida’s drug information center started getting a relative flood of calls from pharmacists and doctors asking about the medicine. Hendeles and a colleague, Doctor of Pharmacy Randy Hatton, collaborated. Hatton got copies of the original studies the FDA used decades ago to approve phenylephrine.

Hendeles: And he analyzed that the data and his analysis showed that it wasn't effective, even the data that the FDA had.

The pharmacist duo decided something should be done about what they’d discovered.

Hendeles: And we published a paper, we brought this to FDA's attention. And they ignored it.

Sharyl: What year was that?

Hendeles: 2006 or 7. When they didn't do anything, we filed a citizen’s petition and in response to the citizen’s petition, they called their outside advisory committee to look at the data.

The FDA committee recommended studies to see if maybe the decongestants just needed to up the dose of the ingredient that didn’t seem to work.

Hendeles: One of the companies did actually do some studies at higher doses, and they, in a blinded study that looked at various doses, they found that even four times the maximum FDA recommended dose was no difference than placebo.

Meantime, years passed and the FDA didn’t act. Then in 2015, Hendeles and his partner wrote an editorial again questioning the effectiveness of phenylephrine. And they filed a second petition asking the FDA to take it off the market.

Hendeles: And FDA sat on that petition for five or six years before doing anything. And in 2023, they had put together an internal scientific committee within the FDA to look at all of this data. And that committee determined that the drug wasn't effective and we were right. And so they then called another advisory committee meeting in September of 2023. And these outside advisors with none of them had any conflict of interest judged that we were, that the FDA was correct and we were correct that it was not effective. And, they still haven't done anything about it.

Hendeles says he personally contacted the FDA to find out why.

Hendeles: I contacted the head of the non-prescription drug division and she gave me ice in the winter. She said that they were looking into it, and, but they haven't acted. I suspect that there's a problem 'cause it's in 261 products. And I think the lobbying group for the manufacturers of non-prescription drugs, probably has pushed back on the FDA's determination that it wasn't effective.

The industry lobby group says phenylephrine is a safe and effective decongestant and that the FDA Advisory Committee is “at odds with the numerous clinical trials.”

For now, Hendeles says two things that DO work for cold and allergy stuffiness are nose sprays with phenylephrine or steroids. And if you think your store shelf bought decongestant isn’t working, it’s not your imagination.

Sharyl (on-camera): Hendeles says there are other common non-prescription products with the same MO and that Congress should examine the broken FDA system that allowed them on the market and keeps them there.