Science
An FDA committee has ruled that a key ingredient in popular meds like Dayquil and Sudafed PE doesn’t work. But an alternative has always existed.
ByCarrie Arnold
Published September 20, 2023
• 5 min read
Oral decongestants like Sudafed PE and Dayquil are under scrutiny—and soon there might only be one such drug left available to consumers: pseudoephedrine.
On September 12, a group of U.S. Food and Drug Administration (FDA) advisors unanimously voted that phenylephrine—a popular ingredient in cold, cough, and allergy medications—didn’t relieve symptoms any better than placebo.
“We’re approaching $2 billion a year in sales for a product that doesn’t work,” says Randy Hatton, a clinical professor at the University of Florida College of Pharmacy.
Phenylephrine surged in popularity after a 2006 law that moved pseudoephedrine (which had been used since the 1920s) behind the pharmacy counter. Because pseudoephedrine can be used illegally to synthesize methamphetamine, the 2006 law was created to prevent the purchase of large amounts of it. The drug is available without a prescription but remains behind the pharmacy counter.
(Are you taking the wrong medications? You might be surprised.)
If the FDA follows the committee’s advice to pull oral phenylephrine from the shelves, consumers may have to turn to pseudoephedrine, says Hatton.
As North America heads into cold and flu season, medical experts say it’s crucial that the public understands their options.
How does pseudoephedrine work?
The two most common reasons most of us end up with a stuffy nose are either due to a virus (such as the common cold, influenza, or COVID-19) or allergies from pollen, pet dander, or house dust.
“The inside of the nose acts as a filter for our body and for our lungs. And these filters are lined with things to respond to the environment,” says Matthew Rank, an allergist and immunologist at Mayo Clinic in Arizona.
The body reacts to both allergies, viruses, and other irritants by causing the small blood vessels lining your nose to swell. This is followed by an increase in mucus production, which is the body’s attempt to remove the allergen or pathogen that is in the nose. What results is a feeling of fullness or stuffiness in the nose that can make it hard to breathe.
(Feeling sick? Here’s how other cold and flu drugs work.)
Both pseudoephedrine and phenylephrine are thought to work by shrinking blood vessels, thus making it easier to breathe.
What’s the difference between pseudoephedrine and phenylephrine?
Since both pseudoephedrine and phenylephrine work by constricting blood vessels, it’s tempting to think that they would both be effective. That’s not the case, says Mark Dykewicz, an allergist and immunologist at Saint Louis University.
“One works and the other one doesn’t,” he says.
The difference has to do with what happens after someone swallows medication containing phenylephrine or pseudoephedrine. Phenylephrine is rapidly broken down by the liver into small molecules called metabolites. These metabolites are what enter the bloodstream to reach the nose. Research presented at the FDA committee meeting showed only 1 percent of the phenylephrine taken in pill form reaches the nose. “The amount is negligible,” Dykewicz says.
Pseudoephedrine is not broken down much by the liver, which allows more active drug to travel to the nose and shrink blood vessels.
Why can’t you get pseudoephedrine off the shelf?
Although pseudoephedrine is most commonly used as a decongestant, it is actually part of a class of stimulants called amphetamines. Back in the 1920s, people who took pseudoephedrine as a stimulant also noticed that it relieved their stuffy noses.
(How did Viagra get its name? Through this fascinating process.)
Since pseudoephedrine is chemical kissing cousins with methamphetamine, people who wanted to synthesize the powerful drug at home could convert large amounts of readily available (legal) pseudoephedrine into (illegal) meth with a few quick steps. To prevent at-home meth cooking, federal officials moved pseudoephedrine behind the counter in 2006, limiting the amount that can be purchased and requiring valid ID.
Are there any risks of taking pseudoephedrine?
Both pseudoephedrine and phenylephrine have an FDA designation of GRAS: Generally Regarded as Safe. But this is only true if the medications are taken as directed on the label, Hatton says. Since pseudoephedrine is often sold in combination with other medications, such as cough suppressants and anti-inflammatory medications such as acetaminophen (Tylenol), it’s especially important to not use more than directed.
Pseudoephedrine is particularly a concern for people at high risk of heart attack and stroke, precisely because it works by constricting blood vessels. “It doesn’t just constrict the blood vessels in your nose. It constricts vessels throughout the whole body,” Hatton says. Rank adds that he often encourages his patients to seek alternate remedies.
What if I don’t want to take medication for my congestion?
All the experts who spoke with National Geographic recommended saline rinses to help relieve nasal congestion. Over-the-counter saline sprays are available, as are Neti pots and other nasal irrigation systems. Rank cautions people to only used distilled water or water that has been boiled and cooled to prevent infections from Naegleria fowleri, the so-called “brain eating amoeba.”
Congestion caused by the common cold is self-limited, and Hatton recommends that patients drink lots of fluids and rest.
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