The main decongestant used by millions of people seeking relief from a stuffy nose is no better than a placebo, according to government experts who reviewed the most recent study on the questioned ingredient.
Advisors to the U.S. Food and Drug Administration voted unanimously Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil and other drugs available on store shelves. .
“Modern studies, when well done, show no improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergist at Saint Louis University School of Medicine.
The FDA brought together its outside advisers to take another look at phenylephrine, which became the leading over-the-counter decongestant drug when drugs with an older ingredient — pseudoephedrine — began to be sold only by prescription. A 2006 law required this because pseudoephedrine can be illegally transformed into methamphetamine.
Those 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 market for oral decongestants. Versions with phenylephrine, sometimes labeled “PE” on packaging, make up the rest.
If the FDA follows the panel’s recommendations, Johnson & Johnson, Bayer and other manufacturers could be forced to remove oral medications containing phenylephrine from shelves. This would force consumers to resort to over-the-counter products containing pseudoephedrine or to sprays and nasal drops containing phenylephrine.
In that case, the FDA would need to work with pharmacies, pharmacists and other health care professionals to inform consumers about remaining options for treating congestion, group members 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,” said Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think, as far as I’m concerned, this is a closed case. It does not work”.
This week’s two-day meeting was prompted by University of Florida researchers who asked the FDA to recall most phenylephrine products based on recent studies showing they did not outperform placebo pills in patients with congestion from colds. and allergies. The same researchers also questioned the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.
That was also the recommendation of the FDA’s outside experts at the time, who held a similar meeting on the drug in 2007.
This time, all 16 members of the FDA panel agreed that current evidence does not show the drug has any benefit.
“I think this medication in its oral dosage 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 don’t believe this medication will do that.”
The advisers essentially endorsed 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 the agency no longer accepts, according to regulators.
“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, more rigorous studies published since 2016 showed no difference between phenylephrine medications and placebos in relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.
A trade group representing over-the-counter drug makers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have “ready access” to phenylephrine.
Like many other over-the-counter ingredients, phenylephrine was approved during a broad FDA review that began in 1972. It has been sold in various forms for more than 75 years, before the agency’s own regulations went into effect. on the effectiveness of medications.
“When 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 heads the FDA’s office of over-the-counter drugs.
But FDA reviewers said their latest assessment reflects new knowledge from testing about how quickly phenylephrine is metabolized when taken orally, leaving only trace levels reaching the nasal passages to relieve congestion. The drug appears to be most effective when applied directly to the nose, in sprays or drops, and those products are not being reviewed.
Tuesday’s vote, which is non-binding, is unlikely to have immediate consequences.
The group’s negative opinion opens the door for the FDA to remove phenylephrine from a federal list of decongestants considered effective for over-the-counter pills and liquids. The FDA said recalling the products would eliminate “the unnecessary costs and delay in care of taking a drug that has no benefit.”
The FDA’s list of nasal decongestant medications, or monograph, has not been updated since 1995. The process to change a monograph has traditionally taken years or decades, requiring multiple rounds of review and public comments. But a 2020 law passed by Congress streamlines the process, which should allow the FDA to speed up the publication of new rules for over-the-counter ingredients.
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