Sudafed and other common nasal decongestants containing pseudoephedrine are displayed behind the counter at a hospital discount pharmacy in Edmond, Oklahoma, January 11, 2005.
AP
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Sudafed and other common nasal decongestants containing pseudoephedrine are displayed behind the counter at a hospital discount pharmacy in Edmond, Oklahoma, January 11, 2005.
AP
WASHINGTON — The leading nasal decongestant used by millions of Americans to relieve stuffy noses is the main one, according to government experts who reviewed the latest research into the drug’s long-questioned ingredients. , they say it’s no different from a dummy pill.
Food and Drug Administration advisers on Tuesday unanimously voted against the effectiveness of a key drug in popular versions of Sudafed, Dayquil and other drugs on the shelves.
“The most recent studies, even when done properly, do not show that phenylephrine improves congestion,” said Dr. Mark Dykewicz, an allergist at Saint Louis University School of Medicine.
The FDA brought in outside advisors to take another look at phenylephrine at a time when drugs containing the older ingredient pseudoephedrine were moved behind pharmacy counters. The 2006 law enforced this measure because pseudoephedrine can be illegally processed into methamphetamine.
Although these original versions of Sudafed and other drugs are still available without a prescription, they are less popular and account for about one-fifth of the $2.2 billion market for oral decongestants. The phenylephrine version (sometimes labeled “PE” on the package) makes up the rest.
If the FDA follows the committee’s recommendations, Johnson & Johnson, Bayer and other drug companies could be required to remove oral medications containing phenylephrine from their shelves. Consumers will likely be forced to switch to over-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops.
In that scenario, the FDA would need to work with drugstores, pharmacists and other health care providers to educate consumers about remaining congestion treatment options, panelists said Tuesday.
The group also told the FDA that studying phenylephrine in higher doses was not an option because it could push blood pressure to potentially dangerous levels.
“I think there are safety issues,” said Dr. Paul Pisaric of Archewell Health in Oklahoma. “As far as I’m concerned, I think this is a done deal. It’s not going to work.”
This week’s two-day conference was prompted by researchers at the University of Florida, who based on a recent study showing that phenylephrine products were not more effective than placebo pills in patients with cold and allergy congestion. petitioned the FDA to remove phenylephrine products. The same researchers challenged the drug’s effectiveness in 2007, but the FDA allowed the product to remain on the market pending further research.
This was also the recommendation of FDA’s outside experts who held a similar meeting on the drug in 2007.
This time, the 16 members of the FDA panel unanimously agreed that current evidence does not show any benefit for this drug.
“I think this oral dose of this drug should have been removed from the market a long time ago,” said Jennifer Schwartzott, a patient representative on the committee. “Patients need and deserve drugs that safely and effectively treat their symptoms, and I do not believe this drug will do that.”
Advisers essentially supported the conclusions of the FDA’s scientific review released ahead of this week’s meeting, finding that research from the 1960s and 1970s supporting phenylephrine’s original approval had numerous flaws. It turned out that The regulator said the study was “extremely small” and used statistical and research methods that the regulator no longer accepts.
“The bottom line is that none of the original studies met modern standards of research design or conduct,” said Dr. Peter Starke, the agency’s chief medical reviewer.
Additionally, three large, rigorously conducted studies published since 2016 showed no difference between phenylephrine drugs and a placebo for relieving congestion. These studies were conducted by Merck & Co. and Johnson & Johnson and enrolled several hundred patients.
The Consumer Healthcare Products Association, a trade group representing over-the-counter drug manufacturers, said the new study had limitations and argued that consumers should continue to have “easy access” to phenylephrine.
Like many other over-the-counter drug ingredients, phenylephrine was essentially approved in an FDA sweeping review that began in 1972. It has been sold in various forms for more than 75 years, even before the FDA created its own regulations regarding the drug’s effectiveness.
“When a product has been on the market for a long time, it’s human nature to make assumptions about what we think we know about it,” said Dr. Teresa Michele, head of the FDA’s Division of OTC Drugs. ” he says.
But FDA reviewers said the latest evaluation is based on new tests of how quickly phenylephrine is metabolized when taken orally, leaving only trace levels reaching the nasal passages to relieve nasal congestion. said that it reflects the insight of The drug is thought to be more effective when applied directly to the nose as a spray or drops, but those products have not been reviewed.
Tuesday’s panel vote, which is non-binding, is unlikely to have an immediate impact.
The group’s negative opinion opens the door for the FDA to remove phenylephrine from the federal list of effective nasal decongestants in over-the-counter tablets and liquids. The FDA said removing the product would eliminate “unnecessary costs and delays in taking medications with no benefit.”
The FDA’s list of nasal decongestants, or monographs, has not been updated since 1995. The process of changing a monograph has traditionally taken years or even decades and required multiple rounds of review and public comment. But a 2020 law passed by Congress streamlines the process and should allow the FDA to speed up publication of new standards for over-the-counter ingredients.
