WASHINGTON (AP) — Changes are coming to the cold and cough aisle of your local pharmacy: 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.
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.
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.
Oral phenylephrine medicines will still be with us for a while.
Government regulators must follow a public, multistep process to remove the ingredient from FDA’s list of drugs approved for over-the-counter decongestants.
For six months, the FDA must take comments on its proposal, including from consumers and companies. Then, the FDA must review the feedback before writing a final order. Even after that decision is finalized, companies will likely have a year or more to remove or reformulate products.
Drugmakers could further delay the process by requesting additional FDA hearings.
For now, the Consumer Healthcare Products Association — which represents medicine makers — wants the products to stay available, saying Americans deserve “the option to choose the products they prefer for self-care.”
Hatton says he and his colleagues disagree: “Our position is that choosing from something that doesn’t work isn’t really a choice.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
A decongestant pill containing phenylephrine is displayed for a photograph in Philadelphia on Monday, Dec. 9, 2024. (AP Photo/Jonathan Poet)
Decongestant pills containing phenylephrine are displayed for a photograph in Philadelphia on Monday, Dec. 9, 2024. (AP Photo/Jonathan Poet)
Decongestant pills containing phenylephrine are 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)
NEW YORK (AP) — The man accused of fatally shooting the CEO of UnitedHealthcare pleaded not guilty on Monday to state murder and terror charges while his attorney complained that statements coming from New York's mayor would make it tough to receive a fair trial.
Luigi Mangione, 26, was shackled and seated in a Manhattan court when he leaned over to a microphone to enter his plea. The Manhattan district attorney formally charged him last week with multiple counts of murder, including murder as an act of terrorism, in a state case that will run parallel to his federal prosecution.
His initial appearance in New York's state trial court was preempted by federal prosecutors bringing their own charges over the shooting. The federal charges could carry the possibility of the death penalty, while the maximum sentence for the state charges is life in prison without parole.
Prosecutors have said the two cases will proceed on parallel tracks, with the state charges expected to go to trial first.
One of Mangione’s attorneys told a judge that government officials, including New York Mayor Eric Adams, have turned Mangione into a political pawn, robbing him of his rights as a defendant and tainting the jury pool.
“I am very concerned about my client’s right to a fair trial,” said Karen Friedman Agnifilo.
The city's mayor and top police official stood among a throng of heavily armed officers last Thursday when Mangione was flown to a Manhattan heliport and slowly escorted up a pier after being extradited from Pennsylvania.
“I wanted to look him in the eye and say you carried out this terroristic act in my city — the city that the people of New York love,” the mayor told a local TV station.
Friedman Agnifilo has accused federal and state prosecutors of advancing conflicting legal theories, calling their approach confusing and highly unusual. “He is being treated like a human pingpong ball between warring jurisdictions here,” she said Monday.
State trial court Judge Gregory Carro responded that he has little control over what happens outside the courtroom, but said he can guarantee that Mangione will receive a fair trial.
Authorities say Mangione gunned down Brian Thompson as he was walking to an investor conference in midtown Manhattan on the morning of Dec 4.
Mangione was arrested in a Pennsylvania McDonald’s after a five-day search, carrying a gun that matched the one used in the shooting and a fake ID, police said. He also was carrying a notebook expressing hostility toward the health insurance industry and especially wealthy executives, according to federal prosecutors.
At a news conference announcing the state charges last week, Manhattan DA Alvin Bragg said the application of the terrorism law reflected the severity of a “frightening, well-planned, targeted murder that was intended to cause shock and attention and intimidation.”
“In its most basic terms, this was a killing that was intended to evoke terror,” he added.
Mangione is being held in a Brooklyn federal jail alongside several other high-profile defendants, including Sean “Diddy” Combs and Sam Bankman-Fried.
Outside the courthouse where Mangione appeared Monday, a few dozen supporters chanted, “Free Luigi,” over the blare of a trumpet.
Natalie Monarrez, a 55-year-old Staten Island resident, said she joined the demonstration because she lost both her mother and her life savings as a result of denied insurance claims.
“As extreme as it was, it jolted the conversation that we need to deal with this issue,” she said of the shooting. “Enough is enough, people are fed up.”
An Ivy-league graduate from a prominent Maryland family, Mangione appeared to have cut himself off from family and friends in recent months. He posted frequently in online forums about his struggles with back pain. He was never a UnitedHealthcare client, according to the insurer.
Thompson, a married father of two high-schoolers, had worked at the giant UnitedHealth Group for 20 years and became CEO of its insurance arm in 2021.
The killing has prompted some to voice their resentment at U.S. health insurers, with Mangione serving as a stand-in for frustrations over coverage denials and hefty medical bills. It also has sent shockwaves through the corporate world, rattling executives who say they have received a spike in threats.
Luigie Mangione is escorted into Manhattan Criminal court for his arraignment on state murder and terror charges in the killing of UnitedHealthcare CEO Brian Thompson, Monday, Dec. 23, 2024, in New York. (AP Photo/Seth Wenig)
A demonstrator holds up a sign while waiting for the arrival of Luigi Mangione for his arraignment at Manhattan Criminal Court, Monday, Dec. 23, 2024, in New York. (AP Photo/Stefan Jeremiah)
Luigie Mangione, center, is escorted into Manhattan Criminal court for his arraignment on state murder and terror charges in the killing of UnitedHealthcare CEO Brian Thompson, Monday, Dec. 23, 2024, in New York. (AP Photo/Seth Wenig)
Luigie Mangione is escorted into Manhattan Criminal court for his arraignment on state murder and terror charges in the killing of UnitedHealthcare CEO Brian Thompson, Monday, Dec. 23, 2024, in New York. (AP Photo/Seth Wenig)
Karen Friedman Agnifilo, right, attorney for Luigi Mangione, arrives at Manhattan Criminal Court, Monday, Dec. 23, 2024, in New York. (AP Photo/Stefan Jeremiah)
Luigi Mangione, charged with the fatal shooting of UnitedHealthcare CEO Brian Thompson, is escorted by police in New York, Dec. 19, 2024. (AP Photo/Pamela Smith)