Washington—— The main decongestant used by millions of Americans seeking relief from nasal congestion may be no better than counterfeit pills, government experts reviewing new research on the ingredients of a long-questioned drug say.
Advisors to the U.S. Food and Drug Administration voted unanimously Tuesday against the effectiveness of an ingredient found in popular versions of Sudafed, Allegra, Dayquil and other drugs on store shelves.
“Modern studies, when done properly, have not shown any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at Saint Louis University School of Medicine.
The FDA called in outside consultants to take another look at phenylephrine, which became the mainstay of over-the-counter decongestants when drugs containing the older ingredient pseudoephedrine were moved to pharmacy counters. A 2006 law forced the move because pseudoephedrine can be illegally processed into methamphetamine.
The original versions of Sudafed and other drugs are still available without a prescription, but they are less popular and account for about a fifth of the $2.2 billion oral decongestant market. The remainder consists of the phenylephrine version (sometimes labeled “PE” on the package).
If the FDA follows the panel’s recommendations, Johnson Johnson & Johnson, Bayer AG and other drugmakers may be required to pull oral medications containing phenylephrine from store shelves. That could force consumers to turn to over-the-counter medications or nasal sprays and drops containing phenylephrine, which have yet to be reviewed.
In that case, the FDA will have to work with pharmacies, pharmacists and other health care providers to educate consumers about remaining options for treating congestion, panel members said Tuesday.
Advisors also told the FDA that studying higher doses of phenylephrine was not an option because it could push blood pressure to dangerous levels.
“I think there’s a safety issue there,” said Dr. Paul Pisarik of Acgewell Health in Oklahoma. “I think it’s a done deal as far as I’m concerned. It’s not going to work.”
This week’s two-day meeting was sponsored by researchers at the University of Florida, who are asking the FDA to remove phenylephrine products because recent studies show they fail to be better at treating people with colds and allergy congestion. Placebo pills. In 2007, these researchers also raised questions about the drug’s effectiveness, but the FDA allowed the product to remain on the market pending further studies.
That was also the advice of the FDA’s outside experts at the time, who held a similar meeting on the drug in 2007.
This time, the 16 members of the FDA panel agreed that current evidence does not show any benefit from the drug.
“I feel like this oral dose of the drug should have been taken off the market a long time ago,” said Jennifer Schwartzott, a patient representative on the panel. “Patients need and deserve medicines that safely and effectively treat their symptoms, but I’m not convinced this medicine can do that.”
Advisors largely supported the conclusions of the FDA’s scientific review issued before this week’s meeting, which found numerous flaws in the studies in the 1960s and 1970s that supported phenylephrine’s original approval. The regulator said the studies were “extremely small” and used statistical and research techniques that the agency no longer accepts.
“The bottom line is that none of the original studies met modern standards of research design or conduct,” said Dr. Peter Stark, the agency’s chief medical reviewer.
Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between the drug phenylephrine and a placebo in relieving congestion.The studies were conducted by Merck & Johnson & Johnson and enrolled hundreds of patients.
The Consumer Healthcare Products Association, a trade group representing over-the-counter drug manufacturers, argued that the new study had limitations and that consumers should continue to have “easy access” to phenylephrine.
Like many other over-the-counter ingredients, phenylephrine essentially came into use during the FDA’s sweeping review that began in 1972. It has been sold in various forms for more than 75 years, predating the FDA’s own regulations on drug effectiveness.
“Anytime a product is on the market for that long, it’s human nature that we make assumptions about what we know about that product,” said Dr. Theresa Michele, director of the FDA’s Office of OTC Drugs.
But FDA reviewers said their latest assessment reflects new testing insights into how quickly oral phenylephrine is metabolized, leaving only trace levels to reach the nasal passages to relieve congestion. The drug appears to be more effective when sprayed directly into the nose as a spray or drops.
Tuesday’s panel vote is unlikely to have any immediate impact because it is non-binding.
The group’s negative opinion opens the door for the FDA to remove phenylephrine from the federal list of decongestants – decongestants considered effective in over-the-counter medications and liquids. The FDA said removing these products would eliminate “unnecessary costs and delays in taking medications that have no benefit.”
The FDA’s nasal decongestant drug list (or monograph) has not been updated since 1995. The process of changing a monograph has traditionally taken years or decades, requiring multiple rounds of review and public comment. But a 2020 law passed by Congress streamlined the process, which will allow the FDA to expedite the issuance of new standards, dosages and labels for over-the-counter ingredients.
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