WASHINGTON — U.S. officials are moving to phase out the leading decongestant found in hundreds of over-the-counter medicines, concluding that it doesn’t actually relieve nasal congestion.

Phenylephrine is used in popular versions of Sudafed, Dayquil and other medications, but experts have long questioned its effectiveness. Last month, the Food and Drug Administration formally proposed revoking its use in pills and liquid solutions, kicking off a process that’s likely to force drugmakers to remove or reformulate products.

It’s a win for skeptical academics, including researchers at the University of Florida who petitioned the FDA to revisit the drug’s use in 2007 and again in 2015. For consumers, it will likely mean switching to alternatives, including an older decongestant that was moved behind the pharmacy counter nearly 20 years ago.

Doctors say Americans will be better off without phenylephrine, which is often combined with other medicines to treat cold, flu, fever and allergies.

“People walk into the drugstore today and see 55,000 medicines on the shelf, and they pick one that is definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic. “You take away that option, and it will be easier for them to self-direct toward products that really will help them.”

The FDA decision was expected after federal advisers last year voted unanimously that oral phenylephrine medications haven’t been shown to relieve congestion.

Experts reviewed several recent, large studies indicating that phenylephrine was no better than a placebo at clearing nasal passageways. They also revisited studies from the 1960s and 1970s that supported the drug’s initial use, finding numerous flaws and questionable data.

The panel’s opinion only applied to phenylephrine in oral medications, which account for roughly $1.8 billion in annual U.S. sales. The drug is still considered effective in nasal sprays, though those are much less popular.

Phenylephrine wasn’t always the top choice for cold and allergy products. Many were originally formulated with a different drug, pseudoephedrine.

But a 2006 law required pharmacies to move pseudoephedrine products behind the counter, citing their potential to be processed into methamphetamine. Companies such as Johnson & Johnson and Bayer decided to reformulate their products to keep them readily available on store shelves — and labeled many of them as “PE” versions of familiar brand names.

PHARMACY NEEDED

Consumers who still want to take pills or syrups for relief will probably need to head to the pharmacy counter — where the pseudoephedrine-containing versions of Sudafed, Claritin D and other products remain available without a prescription. Purchasers need to provide a photo ID.

Beyond those products, most of the other options are over-the-counter nasal sprays or solutions.

Saline drops and rinses are a quick way to clear mucus from the nose. For long-term relief from seasonal stuffiness, itching and sneezing, many doctors recommend nasal steroids, sold as Flonase, Nasacort and Rhinocort.

“These medicines are by far the most effective daily treatment for nasal congestion and stuffiness,” Schroer said. “The biggest issue is they’re not great when used on an as-needed basis.”

Nasal steroids generally have to be used daily to be highly effective. For short-term relief, patients can try antihistamine sprays, such as Astepro, which are faster acting.

Phenylephrine-based sprays will also remain on pharmacy shelves.

SWALLOWING STIFLES AID

The experts who challenged the drug’s effectiveness say it’s quickly broken down and rendered ineffective when it hits the stomach.

“This is a good drug, but not when it’s swallowed,” said Leslie Hendeles, professor emeritus at the University of Florida’s College of Pharmacy, where he co-authored several papers on the ingredient. “It’s inactivated in the gut and doesn’t get into the bloodstream, so it can’t get to the nose.”

When Hendeles and his colleagues first petitioned the FDA on phenylephrine, they suggested a higher dose might be effective. But subsequent studies showed that even doses 400% higher than those currently recommended don’t treat stuffiness.

The FDA and other researchers concluded that pushing the dosage even higher might carry safety risks.

“If you’re using very high doses, the risk is raising blood pressure so high that it could be hazardous to patients,” said Randy Hatton, a University of Florida professor who co-led the research on phenylephrine.

Because of its cardiovascular effects, the drug is sometimes used to treat dangerously low blood pressure during surgery, Hatton noted.

    A decongestant pill containing phenylephrine is displayed for a photograph in Philadelphia on Monday, Dec. 9, 2024. (AP Photo/Jonathan Poet)
  

    A decongestant pill containing phenylephrine is displayed for a photograph in Philadelphia on Monday, Dec. 9, 2024. (AP Photo/Jonathan Poet)
  

With the transfer portal in full swing, Arkansas coach Sam Pittman addressed some of the biggest areas of need for his team. The Razorbacks are coming off of a 6-6 finish in the fifth year under Pittman and looking to boost their roster for another run in 2025.

Speaking with media, Pittman highlighted both the offensive and defensive line as the areas where Arkansas needs to be most aggressive in the portal. He also cited the linebacker group as a the position that the team feels best about, saying the Razorbacks will look to improve its defensive backs room first.

“Offensive line would be one (area of need),” the coach said. “Defensive line would be one. We felt like we were pretty good at the linebacker spots. If you go back and look a couple of years ago, the world was falling because this linebacker (left), that linebacker (left).

“I think we all agreed out linebacker room was a strength for us this year. But that would be probably the least worried about (position). We need some safeties. We need some corners. But I think O-line and tight end’s a big deal. Wide receivers. We’ve got several spots to fill, but off the top of my head, that’s who it would be.”

Since Pittman’s comments, Arkansas has been active in the transfer portal to bring in 13 players. Unfortunately, they’ve also lost 26 more and rank just No. 59 out of 70 teams in On3’s Transfer Portal Team Rankings.

Staying true to to his word, Pittman has brought in four offensive linemen and a pair of defensive lineman through the portal. Former Georgia Tech offensive tackle Corey Robinson II is the highest rated of those additions, coming in as the No. 32 overall player and No. 5 player at his position according to On3’s Transfer Portal Player Rankings.

Arkansas also brought in former Charlotte receiver O’Mega Blake and former Cincinnati cornerback Jordan Young to give it three players ranked in the top 150.

The Razorbacks still have a long way to go to complete their portal class, likely hoping to add some more defensive linemen before it closes later this month. They are looking to make the next push in the SEC next season and the players they’ve gotten so far are a good start.

A federal judge ruled on Monday that sections of an Arkansas law, which sought to impose criminal penalties on librarians and booksellers for distributing “harmful” material to children, were unconstitutional.

The law, known as the Arkansas Act 372, was signed into law last year by Republican governor Sarah Huckabee Sanders. It was challenged by a coalition of organizations in the state, leading to a lengthy legal battle that concluded this week.

Two sections of Act 372 subjected librarians and booksellers to jail time for distributing material that is deemed “harmful to children”. Proponents of the law, including Sanders, said the law was put in place to “protect children” from “obscene” material.

“Act 372 is just common sense: schools and libraries shouldn’t put obscene material in front of our kids,” Sanders said in a statement to KATV-TV. “I will work with Attorney General Griffin to appeal this ruling and uphold Arkansas law.”

The governor signed the bill into law in March 2023, and a coalition of organizations in the state, including the Central Arkansas Library System in Little Rock and the ACLU of Arkansas, challenged it last year, saying the law was vague, overly broad and that the fear of criminal penalties would have a chilling effect on librarians across the state. A federal court temporarily blocked the enforcement of the two sections in question, while the law was being challenged in court.

The two sections that were struck down on Monday had established a criminal misdemeanor for “furnishing a harmful item to a minor”, and would have required local governments to create oversight boards to review challenged material. The organizations opposing the law argued that local officials, at their own discretion, could censor whichever books and material they pleased.

“This is a significant milestone on a long, sometimes rocky road we were obligated to travel after the passage of Act 372,” said Nate Coulter, executive director of the Central Arkansas Library System, in response to Monday’s ruling.

“We took that path to protect our librarians from prosecution for doing their jobs and to prevent some local elected officials from censoring library books they did not feel were ‘appropriate’ for our patrons to read.”

In 2004, a federal judge struck down a similar law. The year prior, the state passed a law that required booksellers and librarians to hide materials deemed “harmful to minors”. It was deemed unconstitutional after legal challenges.