Popular decongestant doesn't work, FDA panel finds

A decongestant found in popular nonprescription cold medications including some types of Sudafed, DayQuil and Mucinex doesn’t work, according to a panel of experts reviewing the ingredient phenylephrine for the U.S. Food and Drug Administration.

The unanimous vote on Tuesday could lead the FDA to pull medications with phenylephrine from store shelves, if it accepts the findings. Sales of products with the ingredient were worth $1.7 billion in 2022.

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, a member of the panel and an allergy specialist at the Saint Louis University School of Medicine.

Findings from recent studies as well as interpretation of older data, shows phenylephrine is not effective, said Dr. David Rosenthal, attending physician at the division of allergy/immunology at Northwell Health.

“Science progresses over time, and even though it was approved as being effective in the 1970s, it doesn’t meet the current standards for effectiveness,” he said. “This was typically used as a medication that shrank blood vessels in the nose so people would not be as congested.”

Members of the FDA’s Nonprescription Drug Advisory Committee had been convened to examine data and help determine whether oral phenylephrine is an effective nasal decongestant. The review did not include nasal sprays with phenylephrine.

The debate over the effectiveness of phenylephrine has gone on for over a decade, led by some medical experts and researchers. But sales of products containing the ingredient are strong, especially during the cold and flu seasons. More than 242 million bottles/packages of over-the-counter cough, cold, allergy oral medications with phenylephrine were sold in retail stores in 2022, according to an FDA briefing document.

FDA reviewers said the research shows how quickly phenylephrine is metabolized when taken orally, 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.

Rosenthal said people suffering from allergy symptoms are better off addressing symptoms with antihistamines and seeing an allergist. Cold symptoms will improve when the cold virus goes away with the help of rest, nasal saline and drinking warm liquids.

Rosenthal said preventing infections by getting vaccinated against the flu, COVID-19 and RSV is also important.

Phenylephrine became a key ingredient in over-the-counter decongestants when medicines with another ingredient, pseudoephedrine, were moved behind the counter for safety reasons in 2006. Pseudoephedrine can be used to illegally manufacture methamphetamine. Those medicines are still available but there are some restrictions around their purchase.

“I think the lesson for all consumers is when you're buying these over the counter products, it's really important to understand what ingredients are in each of these medications and what they do and what they don't do,” said Dr. Aaron Westreich, an allergist at ENT and Allergy Associates in Franklin Square. “Even though these therapies are available over the counter, they are still medications and your doctor should be consulted if you are not sure how to use them."

Westreich said medications with pseudoephedrine — the behind the pharmacy counter medication — have proved to be more effective but that the primary treatment for nasal congestion should not be reliant on any decongestant.

“The best treatment of congestion is the use of standard nasal treatments, which include intranasal steroids, intranasal antihistamines, and nasal saline rinses,” he said. “These medications can help achieve better long-term control of your symptoms and have a better safety profile than both oral and nasal decongestants.”

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 “easy access” to phenylephrine.

With The Associated Press

By Lisa L. Colangelo

lisa.colangelo@newsday.com@lisalcolangelo

Lisa joined Newsday as a staff writer in 2019. She previously worked at amNewYork, the New York Daily News and the Asbury Park Press covering politics, government and general assignment.