Change is coming to the cold and cough aisle of your local pharmacy: U.S. officials are moving to phase out the main decongestant found in hundreds of over-the-counter medications, 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, starting a process that would likely force drugmakers to withdraw or reformulate the products.
It’s a victory for skeptical academics, including researchers at the University of Florida, who asked the FDA to review the drug’s use in 2007 and again in 2015. For consumers, it likely means switching to alternatives, including a more effective decongestant. old that moved behind the pharmacy counter almost 20 years ago.
Doctors say Americans will be better off without phenylephrine, which is often combined with other drugs to treat colds, flus, fevers and allergies.
“People walk into the pharmacy today and see 55,000 drugs on the shelf and they pick one that’s definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic. “You take away that option and it’s easier for them to go to the products that are really going to help them.”
Why is the FDA doing this now?
The FDA’s decision was expected after federal advisers last year voted unanimously that oral phenylephrine medications have not been shown to relieve blockages.
Experts reviewed several recent, large studies showing that phenylephrine was no better than a placebo at clearing the nasal passages. They also reviewed studies from the 1960s and 1970s that supported the drug’s initial use, finding numerous flaws and questionable data.
The panel’s opinion applied only to phenylephrine in oral medications, which account for approximately $1.8 billion in annual U.S. sales. The drug is still considered effective in nasal sprays, although they are much less popular.
Phenylephrine was not always the best choice for cold and allergy products. Many were originally formulated with another drug, pseudoephedrine.
But a 2006 law required pharmacies to move pseudoephedrine products over 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 well-known brand names.
What are some alternatives to overcrowding?
Consumers who still want to take pills or syrups for relief will probably have to head to the pharmacy counter — where pseudoephedrine-containing versions of Sudafed, Claritin D and other products remain available without a prescription. Buyers must provide photo ID.
Beyond these products, most 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 puffiness, itching, and sneezing, many doctors recommend nasal steroids, sold as Flonase, Nasacort, and Rhinocort.
“These medications are by far the most effective daily treatment for nasal congestion and bloating,” Schroer said. “The biggest issue is that they’re not great when used as needed.”
Nasal steroids generally need to be used daily to be very effective. For short-term relief, patients can try antihistamine sprays, such as Astepro, which work faster.
Phenylephrine-based sprays will also remain on pharmacy shelves.
Why doesn’t phenylephrine work when taken by mouth?
Experts who have challenged the drug’s effectiveness say it breaks down quickly and becomes ineffective when it hits the stomach.
“This is a good drug, but not when ingested,” said Leslie Hendeles, professor emeritus at the University of Florida College of Pharmacy, where he co-authored several papers on the compound. “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 asked the FDA about phenylephrine, they suggested that a higher dose might be effective. But later studies showed that even doses 400% higher than those currently recommended do not treat choking.
The FDA and other researchers concluded that pushing the dose even higher could pose safety risks.
“If you’re using very high doses, the risk is to raise blood pressure so high that it can be dangerous for patients,” said Randy Hatton, a University of Florida professor who co-led the phenylephrine research.
Because of its cardiovascular effects, the drug is sometimes used to treat dangerously low blood pressure during surgery, Hatton noted.
What happens next?
Oral phenylephrine medications will still be with us for a while. Government regulators must follow a public, multi-step process to remove the ingredient from the FDA’s list of drugs approved for over-the-counter decongestants.
For six months, the FDA must receive comments on its proposal, including from consumers and companies. Then, the FDA must review the feedback before writing a final order. Even after this decision is finalized, companies will likely have a year or more to phase out or reformulate products.
Drugmakers can further delay the process by requesting additional hearings at the FDA.
For now, the Consumer Healthcare Products Association — which represents drugmakers — wants the products to remain 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 something that doesn’t work isn’t really a choice.”
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