
There are changes coming in the cold and cough aisle of your local pharmacies: U.S. officials are moving to phase out leading decongestants found in hundreds of over-the-counter medications, concluding that they don’t actually relieve nasal congestion.
Phenylephrine is used in common versions of Sudafed, Dayquil and other drugs, but experts have long questioned its effectiveness. Last month the Food and Drug Administration Officially proposed Eliminate its use in pills and liquid solutions, setting in motion a process that will likely force drug makers to remove or reformulate products.
It’s a win for skeptical academics, including researchers at the University of Florida who petitioned the FDA to reconsider the use of the drug in 2007 and again in 2015. For consumers, it likely means turning to alternatives, including That’s an old decongestant that was moved behind the pharmacy. counter for nearly 20 years.
Doctors say Americans would be better off without phenylephrine, which is often combined with other medications to treat cold, flu, fever and allergies.
“People walk into a pharmacy today and see 55,000 medications on the shelf, and they choose one that is definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic. “If you eliminate that option, it will be easier for them to orient themselves toward products that will really help them.”
Why is the FDA doing this now?
The FDA’s decision was expected after federal advisors last year They voted unanimously Oral phenylephrine medications have not been shown to relieve congestion.
Experts reviewed several recent, large studies suggesting that phenylephrine was no better than placebo at clearing nasal passages. They also reviewed studies conducted in the 1960s and 1970s that supported the drug’s initial use, finding many flaws and questionable data.
The committee’s opinion applies only to phenylephrine found in oral medications, which account for about $1.8 billion in annual sales in the United States. Nasal sprays are still effective, although they are less common.
Phenylephrine hasn’t always been the best choice for cold and allergy products. Many were originally manufactured using a different drug, pseudoephedrine.
But a 2006 law requires pharmacies to carry pseudoephedrine products behind the counter, citing the possibility of them being processed into methamphetamine. Companies like Johnson & Johnson and Bayer have decided to reformulate their products to keep them readily available on store shelves — branding many of them as “PE” versions of familiar brand names.
What are some alternatives to crowding?
Consumers who still want to take a pill or drink to relieve pain may need to head to the pharmacy — where pseudoephedrine-containing versions of Sudafed, Claritin D and other products remain available without a prescription. Buyers need to provide photo ID.
In addition to these products, most other options are over-the-counter nasal sprays or solutions.
Saline drops and rinses are a quick way to remove mucus from the nose. For long-term relief of seasonal stuffiness, itching, and sneezing, many doctors recommend nasal steroids, sold as Flonase, Nasacort, and Rhinocort.
“These medications are the most effective daily treatment for nasal congestion and stuffy nose,” Schroer said. “The biggest problem is that it’s not great when used on an as-needed basis.”
Nasal steroids generally must be used daily to be most effective. For short-term relief, patients can try antihistamine sprays, such as Astepro, which act faster.
Sprays containing phenylephrine will also remain on pharmacy shelves.
Why doesn’t phenylephrine work when taken orally?
Experts who doubted the effectiveness of the drug say that it decomposes quickly and becomes ineffective when it reaches the stomach.
“This is a good drug, but not when you swallow it,” said Leslie Hindless, a professor emeritus at the University of Florida College of Pharmacy, where he co-authored several research papers on the ingredient. “It’s stuck in the gut and doesn’t get into the bloodstream, so it can’t get into the nose.”
When Hindless and colleagues first petitioned the FDA about phenylephrine, they suggested that a higher dose might be effective. But subsequent studies have shown that even doses 400% higher than those currently recommended do not cure choking.
The FDA and other researchers have concluded that pushing the dose to higher levels may carry safety risks.
“If you use very high doses, the risk is that it raises blood pressure so much that it can be dangerous to patients,” said Randy Hutton, a professor at the University of Florida who co-led the research on phenylephrine.
Because of its effects on the heart and blood vessels, the drug is sometimes used to treat dangerously low blood pressure during surgery, Hatton noted.
What will happen next?
Oral phenylephrine medications will be with us for a while.
Government regulators must follow a public, multi-step process to remove the ingredient from the US Food and Drug Administration’s (FDA) approved drug list for over-the-counter decongestants.
For six months, the FDA must receive comments on its proposal, including from consumers and businesses. Next, the FDA must review the comments before writing the final order. Even after this decision is finalized, companies will likely have a year or more to remove or reinstall the products.
Drug makers can delay the process further by requesting additional hearings from the FDA.
For now, the Consumer Healthcare Products Association — which represents drug makers — wants the products to remain available, saying Americans deserve “the option to choose the products they prefer for self-care.”
Hutton says he and his colleagues disagree: “Our position is that choosing from something that doesn’t work isn’t really a choice.”