A major decongestant used by millions of Americans looking for relief from blocked noses is probably no better than a dummy pill, according to government experts who reviewed the latest research on a long-discussed drug ingredient.
Food and Drug Administration advisers voted unanimously Tuesday against the effectiveness of an ingredient found in popular versions of Sudafed, Allegra, Dayquil and other drugs sold on pharmacy shelves.
“Modern studies, when well done, are showing no improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergist at 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 drugs containing the older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law forced the move because pseudoephedrine can be illegally processed into methamphetamine.
Those original versions of Sudafed and other drugs are available without a prescription, but they account for about one-fifth of the $2.2 billion market of oral decongestants. Phenylephrine versions – sometimes labeled “PE” on packaging – make up the rest.
If the FDA follows the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to remove their oral medications containing phenylephrine from store shelves. This will likely force consumers to switch to retrograde versions of the pills or nasal sprays and drops that contain phenylephrine, which are not under review.
This week’s two-day meeting was prompted by researchers at the University of Florida, who petitioned the FDA to delist phenylephrine products based on recent studies showing they may be effective in patients with cold and allergy congestion. Had failed to perform better than placebo pills. The same researchers also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.
This 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 the current evidence shows no benefit for the drug.
“I think this drug in this oral dosage should have been removed from the market a long time ago,” said Jennifer Schwartzot, the patient representative on the panel. “Patients need drugs that treat their symptoms safely and effectively and I do not believe this drug does that.”
The advisers essentially endorsed the findings of an FDA scientific review published ahead of this week’s meeting, which found numerous flaws in the studies from the 1960s and 1970s that were originally used to support the approval of phenylephrine. Were. Regulators said the studies were “extremely small” and used statistical and research techniques that are no longer accepted by the agency.
“The bottom line is that none of the original studies met modern standards of study design or conduct,” said Dr. Peter Stark, the agency’s chief medical reviewer.
Additionally, three large, rigorously conducted studies published since 2016 have shown that there is no difference between phenylephrine medications and placebo for congestion relief. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.
The Consumer Healthcare Products Association, a trade group representing non-prescription drug manufacturers, 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 put into mandatory use during an extensive FDA review that began in 1972. It has been sold in various forms for more than 75 years, before the agency’s own regulations on drug effectiveness.
Dr. Theresa Mitchell, who leads the FDA’s office of nonprescription drugs, said, “Whenever a product has been on the market for so long, it’s human nature to be biased about what we think about the product. “We make assumptions about what we know.”
But FDA reviewers said their latest evaluation reflects new trial insights into how rapidly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach the nasal passages to relieve congestion. The medicine appears to be more effective when applied directly to the nose in the form of sprays and drops.
There is no possibility of any immediate impact from Tuesday’s panel vote, which is not binding.
The group’s negative opinion opens the door for the FDA to remove phenylephrine from the federal list of decongestants considered effective for over-the-counter pills and liquids. The FDA said removing the products would “eliminate unnecessary costs and delays in seeking care for a drug that has no benefit.”
The FDA’s nasal decongestant drug list, or monograph, has not been updated since 1995. The process of changing a monograph traditionally takes years or decades, requiring multiple rounds of review and public comment. But 2020 legislation passed by Congress streamlines this process, which should allow the FDA to accelerate the publication of new standards, dosages and labeling for non-prescription ingredients.