(As originally published with additional photos, Tue, September 12th 2023, 3:05 PM EDT)
WASHINGTON (TND) — Cold and flu season is coming but the number one decongestant used by millions of Americans with stuffy noses doesn’t do the job and should be taken off store shelves.
That’s the unanimous verdict by a group of experts who serve as advisers to the Food and Drug Administration.
Tuesday, they all agreed the ingredient found in over-the-counter oral medications is ineffective, likely no better than a dummy pill.
That ingredient is phenylephrine, and it’s found in versions of medications including Sudafed, Allegra, and Dayquil. They’re sometimes labeled “PE” on packaging.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.
Forget an easy fix such as taking a higher dose. The advisers said people shouldn’t do that because phenylephrine could raise blood pressure to dangerous levels.
“I think there’s a safety issue there,” said Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think this is a done deal as far as I’m concerned. It doesn’t work.”
Phenylephrine became popular due to restrictions on an older ingredient called pseudoephedrine.
A 2006 law forced medications with pseudoephedrine behind pharmacy counters because the ingredient can be illegally processed into methamphetamine.
Those original versions are still available without prescriptions but moving them and forcing buyers to ask for them caused sales to drop.
These days, they only account for about one-fifth of the $2.2 billion oral decongestant market. The rest contain phenylephrine.
With the advisors’ vote, the FDA could force drugmakers such as Johnson & Johnson and Bayer to pull their oral medications containing phenylephrine from store shelves.
If that happens, consumers would have to switch to the behind-the-counter pills, or buy nasal sprays and drops with phenylephrine, which are not under review.
It wouldn’t be easy. People would have to learn about the alternatives.
The FDA has been under pressure about phenylephrine since 2007, when University of Florida researchers first challenged the drug’s effectiveness.
All these years later, those researchers found phenylephrine products did not outperform placebo pills in patients with cold and allergy congestion.
“I feel this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the advisory panel. “Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.”
Phenylephrine has been sold in various forms for more than 75 years. That’s before the FDA’s regulations on drug effectiveness.
Then, in 1972, the FDA began a sweeping review. Phenylephrine and many other over-the-counter ingredients were essentially grandfathered into use.
But a recent FDA scientific review found numerous flaws with studies from the 1960s and 1970s that supported phenylephrine’s original approval.
“The bottom line is that none of the original studies stand up to modern standards of study design or conduct,” said Dr. Peter Starke, the agency’s lead medical reviewer.
Three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion.
The tests looked into how quickly phenylephrine is metabolized when taken by mouth. They found only trace levels reached nasal passages to relieve congestion. But phenylephrine applied directly to the nose, in sprays or drops, appeared more effective.
“Any time a product has been on the market that long, it’s human nature to make assumptions about what we think we know about the product,” said Dr. Theresa Michele, who leads the FDA’s office of nonprescription drugs.
A trade group representing nonprescription drugmakers disagrees.
The Consumer Healthcare Products Association argued the new studies had limitations and that consumers should continue to have “easy access” to phenylephrine.
The FDA panel vote is not binding, and no immediate impact is expected.
Information from The Associated Press was used in this story.