Changes are coming to the cold and cough aisle at your local pharmacy. U.S. authorities are moving to phase out a leading nasal decongestant found in hundreds of over-the-counter medications, concluding that they do not actually relieve nasal congestion.
Phenylephrine is used in common 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 tablets and liquid solutions, starting a process that will likely force drugmakers to remove or reformulate their products.
This is a victory for skeptics, including researchers at the University of Florida, who petitioned the FDA to review the drug’s use in 2007 and 2015. For consumers, it will likely mean switching to alternatives such as old nasal decongestants that have been moved to the back of the pharmacy. A counter from nearly 20 years ago.
Doctors say Americans should avoid taking phenylephrine, which is often used with other drugs to treat colds, flu, fevers and allergies.
“When people go to the drugstore today, they see 55,000 different drugs on the shelf, and they end up choosing the one that just won’t work,” said Dr. Brian Schroer of the Cleveland Clinic. . “If you take that option away, it becomes easier for them to turn to products that are truly useful.”
Why is the FDA doing this now?
The FDA’s decision was expected after federal advisers unanimously resolved last year that oral phenylephrine drugs have no proven efficacy in relieving congestion.
Experts reviewed several recent large-scale studies showing that phenylephrine is as good as a placebo in clearing the nasal passages. They also reviewed studies from the 1960s and 1970s that supported the drug’s early use and found numerous flaws and questionable data.
The committee’s opinion applied only to phenylephrine, an oral drug that accounts for about $1.8 billion in annual U.S. sales. The drug is still considered effective as a nasal spray, but its popularity is much less.
Phenylephrine wasn’t always the first choice in cold and allergy products. Many were originally formulated with another drug, pseudoephedrine.
But a 2006 law required pharmacies to move pseudoephedrine products behind the counter because they could be processed into methamphetamine. Companies like Johnson & Johnson and Bayer decided to reformulate their products to make them readily available over the counter, labeling many of them as “PE” versions of familiar brand names.
What are the alternatives to crowding?
Consumers who still want to take pills or syrup to relieve symptoms will likely need to visit a pharmacy counter. There, versions of Sudafed, Claritin D, and other products containing pseudoephedrine are available without a prescription. Purchaser must present photo identification.
Most of the options beyond these products are over-the-counter nasal sprays or solutions.
Saline drops and rinsing are easy ways to remove mucus from your nose. For long-term relief from seasonal stuffiness, itching, and sneezing, many doctors recommend nasal steroids, sold as Flonase, Nasacort, and Rhinocort.
“These drugs are by far the most effective daily treatment for nasal congestion and congestion,” Schroer said. “The biggest problem is that it’s not very effective when used on an as-needed basis.”
Nasal steroids usually need to be used daily to be highly effective. For short-term relief, you can try a faster-acting antihistamine spray such as Astepro.
Phenylephrine-based sprays also remain on pharmacy shelves.
Why is phenylephrine ineffective when taken orally?
Experts who have challenged the drug’s effectiveness say it breaks down quickly once it reaches the stomach, rendering it ineffective.
“It’s a good drug, but it’s not when you swallow it,” says Leslie Henderes, a professor emeritus at the University of Florida College of Pharmacy who has co-authored several papers on the ingredient. “It doesn’t reach the nose because it’s inactivated in the intestines and doesn’t enter the bloodstream.”
When Henderes and his colleagues first petitioned the FDA regarding phenylephrine, they suggested that higher doses might be effective. But subsequent studies showed that doses 400% higher than currently recommended did not treat breathlessness.
The FDA and other researchers concluded that further increasing the dose may pose a safety risk.
“If you use very high doses, you run the risk of very high blood pressure, which can be dangerous for patients,” said Randy Hutton, a professor at the University of Florida who co-led the phenylephrine study.
Because of its cardiovascular effects, the drug is sometimes used to treat dangerously low blood pressure during surgery, Hutton noted.
What happens next?
Oral phenylephrine medication will continue for some time yet.
Government regulators must follow a public, multi-step process to remove the ingredient from the FDA’s list of drugs approved as over-the-counter nasal decongestants.
The FDA will have six months to accept comments on the proposal from consumers, businesses and others. The FDA must then review the feedback before making a final order. Even after this decision becomes final, it will likely be a year or more before companies remove or reformulate their products.
Pharmaceutical companies could further delay the process by requesting additional hearings from the FDA.
For now, the Consumer Health Care Products Association, which represents drug manufacturers, wants the products to remain available, saying Americans have “the right to choose the products of their choice for self-care.” .
Hutton said he and his colleagues disagree, saying, “Our position is that choosing between things that don’t work isn’t really a choice.”
