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For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

Now it is up to the FDA to decide whether to ban over-the-counter use of widely used cold and flu decongestants such as Sudafed, Nyquil, Benadryl, Mucinex and Tylenol, which contain phenylephrine. Products that include the ingredient—roughly 250 of them—generated approximately $1.8 billion in sales in 2022, the FDA said.

Data presented to the committee on Monday and Tuesday showed that phenylephrine performed no better than placebo in relieving congestion when given by mouth. Phenylephrine is designed to reduce the swelling of blood vessels but the committee concluded that when it is taken orally not enough of the drug reaches the nasal passages.

“We clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug,” Maria Coyle, chairwoman of the Nonprescription Drugs Advisory Committee (NDAC) and a professor of pharmacy at Ohio State University, said during meeting deliberations.

Nasal sprays that contain phenylephrine are still effective, the FDA said. The drug also is effective for dilating the eyes and for use during surgery.

Revoking phenylephrine’s OTC designation would be disruptive, forcing pharmacies to clear shelves of meds containing the ingredient and requiring companies to reformulate many of their cold and flu products.

“The burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. healthcare system,” the Consumer Healthcare Products Association, said in a release. “The CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications.”

Phenylephrine is one of two oral decongestants available without prescription. Sales of the other, pseudoephedrine, were restricted in 2006 because it can be misused to make methamphetamine. Products with pseudoephedrine are still available OTC but are often behind store counters or locked away, out of the reach of consumers. There also are limitations on how many pills that can be purchased in a store visit.

The restrictions led to a boom in products containing phenylephrine. But soon after their rise in popularity, the FDA’s scrutiny of phenylephrine began. In 2007, the NDAC came to a similar conclusion on its ineffectiveness. While four subsequent studies showed the ineffectiveness of phenylephrine when taken as a pill, there was enough variability in the results to raise questions about how the studies were conducted.

“We do believe that the original studies were methodologically unsound and do not match today’s standard,” Peter Starke, who first led the FDA’s review of phenylephrine, said to the committee. “By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective.”

By Kevin Dunleavy

Source: fiercepharma.com