WASHINGTON The go-to decongestant used by millions of Americans seeking relief from stuffy noses is no better than a fake pill, according to government experts who reviewed the latest research on the long-questioned ingredient.
Food and Drug Administration advisers voted unanimously Tuesday against the effectiveness of the main drug found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.
“Modern studies, when done well, do not show any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at Saint Louis University School of Medicine.
The FDA brought together its outside consultants to take a fresh look at phenylephrine, which became the main drug in over-the-counter decongestants when drugs with an older ingredient, pseudoephedrine, moved behind pharmacy counters. A 2006 law forced the change because pseudoephedrine can be illegally turned into methamphetamine.
These original versions of Sudafed and other medications remain available without a prescription, but are less popular and represent about a fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions, sometimes labeled “PE” on the packaging, make up the rest.
If the FDA follows the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be forced to remove their oral medications containing phenylephrine from store shelves. This would likely force consumers to switch to over-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops.
In that scenario, the FDA would have to work with drugstores, pharmacists and other health care providers to educate consumers about the remaining options for treating congestion, panelists said Tuesday.
The group also told the FDA that studying phenylephrine at higher doses was not an option because it can raise blood pressure to potentially dangerous levels.
“I think there is a safety issue there,” said Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think as far as I’m concerned this is a done deal. It doesn’t work.”
This week’s two-day meeting was prompted by University of Florida researchers who asked the FDA to remove most phenylephrine products based on recent studies showing they failed to outperform placebo pills in cold and allergic congestion patients. The same investigators also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending further investigation.
This was also the recommendation of the FDA’s outside experts at the time, who met for a similar meeting on the drug in 2007.
This time, the 16-member FDA panel unanimously agreed that current evidence shows no benefit for the drug.
“I feel like this medication at this oral dose should have been taken off the market a long time ago,” said Jennifer Schwartzott, a patient representative on the panel. “Patients need and deserve medications that treat their symptoms safely and effectively, and I do not believe this medication will do that.”
The advisers essentially backed the conclusions of an FDA scientific review published before this week’s meeting, which found numerous flaws in studies from the 1960s and 1970s that supported the original approval of phenylephrine. The studies were “extremely small” and used statistical and research techniques that are no longer accepted by the agency, regulators said.
“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 chief medical reviewer.
Additionally, three larger, rigorously conducted studies published since 2016 have shown no difference between phenylephrine and placebo medications for relieving congestion. These studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.
A trade group that represents manufacturers of nonprescription drugs, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have “easy access” to phenylephrine.
Like many other over-the-counter ingredients, phenylephrine was essentially approved during a broad FDA review that began in 1972. It was sold in various forms for more than 75 years, predating the agency’s own regulations on drug effectiveness.
“Whenever a product has been on the market for so 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 nonprescription drugs department.
But FDA reviewers said their latest assessment reflects new knowledge from testing about how quickly phenylephrine is metabolized when taken orally, leaving only traces that reach the nasal passages to relieve congestion. The medicine appears most effective when applied directly to the nose, in sprays or drops, and these products are not under review.
There is unlikely to be any immediate impact from Tuesday’s panel vote, which is non-binding.
The group’s negative opinion opens the door for the FDA to remove phenylephrine from a federal list of decongestants considered effective in over-the-counter pills and liquids. The FDA said removing the products would eliminate “unnecessary costs and delays in treating a drug that provides no benefit.”
The FDA’s list, or monograph, of nasal decongestant medications has not been updated since 1995. The process for changing a monograph traditionally takes years or decades, requiring multiple rounds of review and public comment. But a 2020 law passed by Congress streamlines the process, which should allow the FDA to speed up publishing new standards for nonprescription ingredients.
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