FDA panel to reevaluate the most common over-the-counter decongestant, phenylephrine, criticized as useless

The Food and Drug Administration plans to ask a panel of its outside advisers to reconsider whether the most common decongestant ingredient available over the counter, phenylephrine, is effective. 

There has been a renewed petition to pull it from store shelves over studies showing it was no more effective than a placebo in pills and syrups. 

The April meeting of the FDA's Nonprescription Drugs Advisory Committee will weigh whether the agency should revoke oral phenylephrine's classification as "Generally Recognized as Safe and Effective" because it may be ineffective.

That could pave the way for the FDA to upend the market for these over-the-counter congestion remedies, undoing a 2007 meeting of the same panel that had sided with evidence suggesting it "may be effective" in its current formulation and calling for more studies of higher doses.

That followed efforts to combat illegal manufacturing of methamphetamine, which moved remedies containing another ingredient called pseudoephedrine — used in drugs like Johnson & Johnson's Sudafed — behind pharmacy counters.

"Phenylephrine has been used safely and effectively as a nasal decongestant by American families for generations, and FDA regulations recognize it as safe and effective," the Consumer Healthcare Products Association — an industry trade group of over-the-counter drug manufacturers — said in a statement Friday.

Before the meeting in 2007, a meta-analysis from the group had concluded an oral dose of phenylephrine was effective as an alternative to treat congestion.

"CHPA members continue to follow these regulations. We acknowledge FDA can reevaluate the efficacy of active ingredients – as it is here," the statement added.

But in 2015, pharmacy professors Leslie Hendeles and Randy Hatton submitted a new petition calling on the FDA to pull the drug. 

Since their original petition that led to the 2007 meeting, they cited new data finding phenylephrine was no better than a placebo and renewed criticism around the CHPA's analysis and some "questionable" studies underlying them.

"Let me be clear, oral phenylephrine is not a safety risk," Hatton, a professor at the University of Florida, told CBS News. "It just doesn't work."

Hendeles and Hatton also penned a commentary in 2022 questioning the FDA's inaction on their petition. The paper sparked renewed interest in scrutiny of the drug, described as  "useless" at reaching the bloodstream after being digested.

"I get it. Risk takes priority. But eight years is long enough to wait, you know what I mean? That's millions and millions of dollars wasted on ineffective drugs," said Hatton.

Hatton cited other drugs that have better data supporting their efficacy at treating congestion. He also pointed to nasal spray forms of phenylephrine that appear to work better than their oral counterparts swallowed in capsules or syrups.

"When you take it orally, it goes to the gut. And as it's being absorbed through the gut, there are two enzymes that metabolize it to such a great extent that essentially a very miniscule amount makes it into the bloodstream," said Hatton.

A statement in May last year from the American Academy of Allergy, Asthma & Immunology backed their petition. 

The group argued that keeping oral phenylephrine in over-the-counter drugs "does a disservice to patients who might be prone to taking higher doses than recommended" and unnecessarily delays doctors visits for more effective prescriptions.

Hendeles declined to be interviewed until after his presentation at the FDA's April meeting. The FDA did not immediately respond to a request for comment regarding the meeting.

Hatton says he often uses oral phenylephrine as a case study of how over-the-counter drugs are approved in the U.S. when teaching students at the university's College of Pharmacy. 

"Many of them work in industry. And the ones who are pharmacists, I ask them, what have you heard from consumers? And they all say the same thing: 'Oh, everybody knows that doesn't work. People complain all the time, that doesn't work,'" said Hatton.