WASHINGTON (AP) — The leading decongestant used by millions of Americans seeking relief from a stuffy nose is no better than a dummy pill, say government experts who have reviewed the latest research on the long-questioned active ingredient.
Advisers to the Food and Drug Administration voted unanimously Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra, Dayquil and other drugs available on store shelves.
“Modern studies, when well conducted, show no improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at Saint Louis University School of Medicine.
The FDA gathered its outside advisers to take another look at phenylephrine, which became the main active ingredient in over-the-counter decongestants when drugs containing an older ingredient – pseudoephedrine – made their way behind pharmacy counters. A 2006 law forced the move because pseudoephedrine can be illegally processed into methamphetamine.
These original versions of Sudafed and other medications remain available without a prescription, but they are less popular and account for about a fifth of the $2.2 billion oral decongestant market. 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 that contain phenylephrine from 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 need to work with drug stores, pharmacists and other health care providers to educate consumers about remaining options for treating congestion, panelists said Tuesday.
The group also told the FDA that studying phenylephrine at higher doses is 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 it’s a done deal for me. It doesn’t work.”
This week’s two-day meeting was launched by researchers at the University of Florida, who had petitioned the FDA to remove most phenylephrine products from the market based on recent studies that showed they were effective in patients with the common cold and allergic constipation had no better effect than placebo pills. The same researchers also questioned the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending further study.
That was also the recommendation of the FDA’s external experts at the time, who met for a similar meeting about the drug in 2007.
This time, the 16 members of the FDA panel agreed that the current evidence shows no benefit for the drug.
“I believe that this drug at this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the panel. “Patients need and deserve medications that safely and effectively treat their symptoms, and I don’t believe this medication does that.”
The advisers essentially supported the conclusions of an FDA scientific review released before this week’s meeting, which found numerous deficiencies in the studies from the 1960s and 1970s that supported phenylephrine’s original approval. The studies were “extremely small” and used statistical and research techniques that were 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 examiner.
Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medication and placebo for congestion relief. These studies were conducted by Merck and Johnson & Johnson and included hundreds of patients.
A trade group representing over-the-counter drugmakers, 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 as part of a comprehensive FDA review in 1972. It has been sold in various forms for more than 75 years, predating the agency’s own regulations on drug effectiveness.
“Any time a product has been on the market for this long, it is 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 Non-Prescription Drugs.
But FDA reviewers said their latest review reflects new test results on how quickly phenylephrine is metabolized when taken orally, leaving only trace amounts reaching the nasal passages to relieve congestion. The medication appears to be more effective when applied directly to the nose in sprays or drops, and these products are not tested.
The panel’s vote on Tuesday, which is non-binding, is unlikely to have any immediate impact.
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 removing the products would avoid “unnecessary costs and delays in taking a drug that provides no benefit.”
The FDA’s nasal decongestant drug list or monograph has not been updated since 1995. The process of amending a monograph has traditionally taken years or decades and required multiple rounds of review and public comment. But a law passed by Congress in 2020 streamlines the process and is intended to allow the FDA to expedite the release of new standards for non-prescription ingredients.
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