Health
More than 200 over-the-counter decongestants contain a key ingredient that was just revealed to be ineffective—and cold and flu season is just around the corner. Now what?
ByStacey Colino
Published September 29, 2023
• 9 min read
The recent revelation that a common oral decongestant called phenylephrine doesn’t work has rattled consumers, especially as cold and flu season is imminent and COVID continues to make the rounds.
An ingredient in many over-the-counter (OTC) decongestants, phenylephrine is present in more than 200 different OTC products, including Sudafed PE, Vicks DayQuil, and NyQuil Severe Cold & Flu, Mucinex Fast-Max Severe Congestion and Cough, Tylenol Cold & Flu Severe, and many others. It’s in most products that claim to contain a decongestant, says Jason Talmadge, an ear, nose, and throat physician and assistant professor of otorhinolaryngology at UTHealth Houston.
In 2007, a group of pharmacists petitioned the Food and Drug Administration (FDA) to remove phenylephrine from the market, after presenting evidence of flaws in the original studies and a meta-analysis of studies showing there wasn’t a difference between the decongestant and placebo on patient-reported nasal congestion. Another study, in 2015, involving more than 500 adults with seasonal allergic rhinitis, came to the same conclusion.
Also, in 2015, professors of pharmacy from the University of Florida, who were part of the 2007 group that petitioned the FDA, filed a Citizens’ Petition with the FDA, asking the agency to remove phenylephrine from OTC nasal decongestant drug products because it doesn’t work. In 2022, the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma & Immunology issued a statement of support for the Citizens’ Petition.
Finally, on September 11 and 12, 2023, an advisory committee to the FDA reviewed data and clinical trials that were presented in an 89-page report and concluded that orally administered phenylephrine doesn’t relieve nasal congestion. This left many consumers wondering, Why is this drug on pharmacy shelves if it doesn’t work?
One of the likely reasons: “A safety issue was not raised with this—it’s an effectiveness issue,” says Mark Dykewicz, chief of allergy and immunology at the Saint Louis University School of Medicine who was a member of the FDA non-prescription drug panel that reviewed the data. “The data doesn’t show effectiveness, and I haven’t personally recommended it for years,” he says.
A troubled history
One reason this drug evaded rigorous evaluation is that phenylephrine was patented in 1927 and came into use before World War II. Over the years, it has been used, in different formulations, to treat nasal congestion, hemorrhoids, and priapism (a disorder involving involuntary, prolonged erections of the penis), as well as to dilate pupils or increase blood pressure in ill patients with hypotension.
But it wasn’t until 1976 when the FDA began reviewing OTC cold medicines that it granted phenylephrine “Generally Recognized as Safe and Effective” (GRASE) status as a decongestant.
The GRASE designation was based on “studies that were done in a different era that would not meet our modern standards,” explains Dykewicz. “It was really de facto grandfathering in phenylephrine.”
The problem is this: “When you take it by mouth, it first gets absorbed by the stomach and the liver inactivates 70 percent of it before it gets in the bloodstream,” Talmadge explains. Other studies have shown that only 1 percent of the drug becomes systemically bioavailable. Either way, this means very little of the drug ever reaches the nose, which is where it’s needed.
At one time, there were three decongestant ingredients on the market—phenylpropanolamine, pseudoephedrine (Sudafed), and phenylephrine—each of which had GRASE status. In 2005, the FDA took steps to pull phenylpropanolamine from the OTC market because the drug increased the risk of hemorrhagic strokes in women.
The following year, access to pseudoephedrine was restricted and the drug was placed behind the counter at pharmacies, requiring customers to request it, show ID, and have their purchasing habits of the drug tracked. This was to prevent people from buying large quantities and using it to manufacture methamphetamine, a highly addictive stimulant (pseudoephedrine is a chemical precursor to meth).
After that, “phenylephrine became more commonly used,” says Eli O. Meltzer, a clinical professor of pediatrics in the division of allergy and immunology at the University of California, San Diego. And many OTC multi-ingredient products were reformulated to include phenylephrine instead of pseudoephedrine.
In that respect, says Talmadge, “phenylephrine was in the right place at the right time.”
Meanwhile, phenylephrine’s quietly troubled history—not in terms of safety but as far as efficacy goes—increasingly came to light.
Nevertheless, it wasn’t until September 2023 that a significant step toward regulatory action on phenylephrine was taken. And yet, the drug still remains on the market—for now, anyway.
Experts say that while some consumers are surprised by the announcement that it isn’t effective, others aren’t.
“A lot of people already knew this from their own experience,” says Purvi Parikh, an allergist and immunologist with NYU Langone Health. Even so, she adds, “people are surprised that [the drug] is so widely used even though it was questioned as far back as 2007.”
Some experts also question why it took so long. “We’ve known for a long time that [oral] phenylephrine is ineffective,” Meltzer says.
Others have a better-late-than-never mindset. “The upshot is: We can reduce patients’ financial burden from buying products that are not effective,” says Mark Sullivan, chief pharmacy officer with Vanderbilt Health in Nashville. “The FDA is looking through the data which instills confidence for what they’re doing for public” well-being.
Weighing the options
With cold and flu season approaching, many people are wondering which OTC medicines to stock up on and which ones to ditch. Now, only one of the original three OTC oral decongestants is still available and considered effective: Pseudoephedrine, the one that’s kept behind the pharmacy counter, is the only one that’s acknowledged to work safely.
Even with the news that the oral form of phenylephrine doesn’t relieve nasal congestion, “some people have really strong attachments to some of these medications and think they work,” says Talmadge. “There could be a placebo effect to some of these.” Which means there’s no need to panic and purge your medicine cabinet of any product containing phenylephrine if it helps you.
It’s worth noting that while the FDA advisory committee agreed that when it’s taken orally phenylephrine doesn’t work, the committee didn’t discuss other delivery systems such as nasal sprays. When the drug is used in sprays, drops, or IVs, “phenylephrine works really well,” says Talmadge.
Still, many doctors say that OTC nasal steroid sprays (such as Flonase, Nasacort, and Nasonex) are the most effective approach for reducing nasal inflammation and congestion. But “they don’t work immediately—you have to use them every day,” Talmadge says. Nasal antihistamine sprays (like Astepro) also can be helpful for nasal congestion that’s due to allergies or colds, Parikh says.
In general, “people prefer oral decongestants over nasal sprays,” Dykewicz adds. But “if oral decongestants aren’t getting the job done, nasal sprays can do much better.”
If you want something that works quickly, you can buy oral pseudoephedrine (such as Sudafed) at the pharmacy counter or get an OTC nasal spray with phenylephrine (like Afrin), which is effective in shrinking swollen blood vessels in the nose, Meltzer says.
But neither of these ingredients should be used for more than five days (a cautionary note mentioned on the package label) because they can increase the risk of rebound congestion: As the medication wears off, the nasal passages swell, causing you to feel even more congested than you did previously, explains Princess Ogbogu, division chief of allergy and immunology at Case Western Hospitals in Cleveland. Plus, oral pseudoephedrine can cause problematic side effects such as increased heart rate or palpitations, spikes in blood pressure, or difficulty sleeping.
Another concern with nasal phenylephrine sprays: “Because they’re over the counter, people don’t know when to stop using them,” Parikh says. “If they use it too long, they can damage the lining of the nose and even get perforations with overuse.”
Instead, nasal irrigation with an OTC saline spray or a Neti pot can be helpful in reducing nasal congestion. Just be sure to use distilled water or tap water that has been boiled and cooled to prevent contamination from a water-based amoeba that can lead to brain infections, Dykewicz says.
What’s next for phenylephrine?
So far, the FDA hasn’t removed oral phenylephrine from the market, in the wake of the advisory committee meeting in September, and there isn’t an immediate timeline for making the decision on whether to do so.
Down the road, however, the FDA could issue an order to remove the ingredient from the market, in which case the public would have an opportunity to comment on the issue before next steps are taken.
Ultimately, if the FDA decides to revoke phenylephrine’s GRASE designation, the agency could pull it from the market after working with manufacturers to reformulate products with other ingredients that would effectively treat symptoms of colds or allergies. This would help prevent the cold and sinus aisle of the pharmacy from becoming a wasteland.
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