WASHINGTON (AP) 鈥� The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the .
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.
鈥淢odern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,鈥� said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient 鈥� pseudoephedrine 鈥� were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.
Those original versions of Sudafed and other medicines remain available without a prescription, but they’re less popular and account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions 鈥� sometimes labeled 鈥淧E鈥� on packaging 鈥� make up the rest.
If the FDA follows through on the panel鈥檚 recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.
In that scenario, the FDA would have to work with drugstores, pharmacists and other health 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 push blood pressure to potentially dangerous levels.
鈥淚 think there鈥檚 a safety issue there,鈥� said Dr. Paul Pisaric of Archwell Health in Oklahoma. 鈥淚 think this is a done deal as far as I鈥檓 concerned. It doesn鈥檛 work.鈥�
This week鈥檚 two-day meeting was prompted by University of Florida researchers who petitioned the FDA to remove most phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also , but the FDA allowed the products to remain on the market pending additional research.
That was also the recommendation of FDA’s outside experts at the time, who met for a similar meeting on the drug in 2007.
This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn’t show a benefit for the drug.
鈥淚 feel this drug in this oral dose should have been removed from the market a long time ago,鈥� said Jennifer Schwartzott, the patient representative on the panel. 鈥淧atients require and deserve medications that treat their symptoms safely and effectively and I don鈥檛 believe that this medication does that.鈥�
The advisers essentially backed the conclusions of an published ahead of this week鈥檚 meeting, which found numerous flaws in the 1960s and 1970s studies that supported phenylephrine鈥檚 original approval. The studies were 鈥渆xtremely small鈥� and used statistical and research techniques no longer accepted by the agency, regulators said.
鈥淭he bottom line is that none of the original studies stand up to modern standards of study design or conduct,鈥� said Dr. Peter Starke, the agency鈥檚 lead medical reviewer.
Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.
A trade group representing nonprescription drugmakers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have 鈥渆asy access鈥� to phenylephrine.
Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into approval during a sweeping . It has been sold in various forms for more than 75 years, predating the agency’s own regulations on drug effectiveness.
鈥淎ny time a product has been on the market that long, it鈥檚 human nature to make assumptions about what we think we know about the product,鈥� said Dr. Theresa Michele, who leads the FDA鈥檚 office of nonprescription drugs.
But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose, in sprays or drops, and those products are not under review.
There鈥檚 unlikely to be any immediate impact from Tuesday鈥檚 panel vote, which is not binding.
The group鈥檚 negative opinion opens the door for the FDA to pull phenylephrine from a federal list of decongestants deemed effective for over-the-counter pills and liquids. The FDA said removing the products would eliminate 鈥渦nnecessary costs and delay in care of taking a drug that has no benefit.鈥�
The FDA’s nasal decongestants drug list, or monograph, has not been updated since 1995. The process for changing a monograph has traditionally taken 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 accelerate the publication of new standards for nonprescription ingredients.
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This story has been updated to delete an incorrect reference to Allegra containing phenylephrine.
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