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Decongestant phenylephrine doesn’t work, FDA advisers say

Cold and flu medications, including Nyquil, sit on a store shelf on September 12, 2023 in Miami, Florida.

Joe Raedle | Getty Images

The main ingredient used in many over-the-counter cold and allergy medications doesn’t actually work to clear nasal congestion, a Food and Drug Administration advisory committee said Tuesday.

In a unanimous vote, 16 councilors said oral forms of phenylephrine — a nasal decongestant found in versions of drugs like Nyquil, Benadryl, Sudafed and Mucinex — are not effective in relieving a blocked nose.

The FDA generally follows the advice of its advisory committees, but it is not required to do so. The agency could potentially begin a process to remove phenylephrine from the market, which would require manufacturers to remove widely used cough and cold medications from store shelves and reformulate those products.

This could affect Procter & Gamblethe manufacturer of all versions of Nyquil, and the Johnson & Johnson spin off Kenvuewhich manufactures Tylenol and Benadryl products.

The Consumer Healthcare Products Association, a trade organization representing manufacturers and distributors of over-the-counter drugs, said Tuesday it was “disappointed” by the advisory committee’s vote.

“We encourage the FDA, before making any regulatory decision, to be aware of the full body of evidence supporting this long-standing OTC ingredient, as well as the significant negative unintended consequences associated with any potential change” in regulatory status of phenylephrine, Scott Melville, the organization’s CEO, said in a statement.

Removing phenylephrine from the market could also affect retail pharmacy chains, which make their revenue from selling over-the-counter cold and allergy pills.

Retail stores in the United States sold 242 million bottles of drugs containing phenylephrine last year, a 30% increase from 2021, according to data compiled by FDA staff. These generated $1.8 billion in sales last year, according to the data.

Spokesperson for CVS And Walgreens did not immediately respond to a request for comment.

Without oral phenylephrine, patients will likely be forced to seek liquid and spray versions of the drug or entirely new drugs, which were not included in the FDA advisors’ review.

The two-day advisory committee meeting was organized by University of Florida researchers, who called on the FDA to remove phenylephrine products based on recent studies showing they fail to outperform placebo pills in patients with colds and allergic congestion.

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.

Yet FDA staff, in briefing materials released before this week’s meeting, concluded that oral formulations of phenylephrine do not work at standard doses, or even higher doses. A very small amount of the drug reaches the nose to relieve congestion, agency staff said.

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