Which decongestants are effective? Why the FDA wants to remove a popular drug ingredient

The U.S. Food and Drug Administration is officially taking action to remove phenylephrine, a popular anti-congestion ingredient, from medications taken orally, including some popular over-the-counter cold and flu medications.

Although phenylephrine is still considered safe, a scientific panel advising the FDA found last year that it doesn’t actually work at clearing or “unclogging” your nose when taken by mouth in over-the-counter products. Phenylephrine is still considered effective in nasal spray form.

What is important is that of the FDA message this week currently has no influence on drug sales; the FDA is seeking public comment about the proposed rule. If the health department, after further consultation, decides to change the rules around oral over-the-counter phenylephrine products, it will be removed as an active ingredient and drug manufacturers will have to change their product formulas or eliminate it altogether.

“Based on our review of the available data, and in accordance with the advisory committee’s advice, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” says Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release.

Oral phenylephrine is included in many popular medications, such as some NyQuil, Mucinex, and more types of name and store brand oral medications, although some contain other ingredients besides phenylephrine that can help relieve symptoms. Before the agency’s action, CVS last year withdrew a “small number” of medications containing phenylephrine as a drug. only active ingredient (think Sudafed PE). The company said it will “continue to offer many other oral cough and cold products to meet consumer needs.”

Many people use over-the-counter decongestants for milder symptoms of a virus or to treat their seasonal allergies. This makes them an easy first-line treatment. And according to Dr. Geoffrey Rutledge, chief physician and co-founder of the telemedicine site HealthTapHaving choices when you’re feeling miserable can be one of the most important parts of treatment.

But you don’t have to settle for one option.

“As a practicing physician, I have never recommended that patients use phenylephrine products,” Rutledge told CNET in 2023, after news of the FDA committee’s findings first broke. Instead, he steers them behind the counter to a more effective decongestant, pseudoephedrine, or to other medications if the source of the congestion is allergies.

Medications containing phenylephrine often contain other active ingredients, don’t throw away your medications yet. Here’s what you need to know about finding a decongestant heading into cold, flu, and virus season.

What is Phenylephrine?

Phenylephrine is a decongestant that works by restricting the blood vessels in your nose. It is found in common medications such as Sudafed PE (not the regular Sudafed), Theraflu, Tylenol Sinus, Advil Congestion, NyQuil Severe Cold and Flu products and more. These are medications that do not require a prescription, are readily available on store shelves, and are typically intended to treat other cold or flu symptoms in addition to congestion.

Phenylephrine’s more effective cousin: pseudoephedrine

There is another oral decongestant that works similarly, pseudoephedrine, and research has shown for some time that it is more effective than phenylephrine, according to Dr. Stacia Woodcock, pharmacist and pharmacy editor at GoodRx.

“The idea that phenylephrine doesn’t work is not new to most health care professionals,” Woodcock said in an email last year. “Pseudoephedrine (Sudafed) has been clearly the superior decongestant for some time.”

However, pseudoephedrine is faces more restrictions because it is also a main ingredient used to make methamphetamine. This means that while phenylephrine-containing Sudafed PE is available on store shelves, you will likely need to ask a pharmacist and show ID to purchase regular Sudafed, which contains pseudoephedrine. There are also limits on how much you can buy at once. (Other names for pseudoephedrine medication includes 12 hours of cold maximum strength.)

Due to the restrictions on pseudoephedrine, “most cough and cold medicine manufacturers are turning to phenylephrine to replace pseudoephedrine in their OTC products,” Woodcock said. “This allowed people to purchase it if the pharmacy is closed, if they had reached their monthly limit for pseudoephedrine products, or if they did not have the necessary ID to purchase it.”

Although pseudoephedrine is considered safe for most adults when taken as directed, it also works by constricting blood vessels and acting more like a stimulant. This means it’s a good idea to talk to your doctor before taking a decongestant (especially pseudoephedrine) if you have have certain health problems such as high blood pressure, a heart problem, glaucoma, diabetes or if you are pregnant or breastfeeding. A certain type of antidepressant, monoamine oxidase inhibitors (MAOIs), may also interact with pseudoephedrine and phenylephrine.

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Don’t throw away your medications yet

Oral decongestants containing phenylephrine have been on the market for decades. And according to research information compiled for the FDA meeting by the Consumer Healthcare Products Association, many people are happy with products containing phenylephrine and say they have found a benefit.

According to both Woodcock and Rutledge, it’s fine to continue using products containing phenylephrine if you want to or if you find they help. You’ll likely still get the benefits of the other ingredients in the medication. Nyquil contains phenylephrine for decongestion, as well contains ingredients to reduce fever and pain and suppress cough, which can still provide relief and ease your symptoms during the worst days of your illness. The same goes for other medications containing phenylephrine.

In addition to the effectiveness of other ingredients, we shouldn’t overlook the fact that someone who expects relief from their medication is likely to get it, says Rutledge. He called this dynamic duo effect on phenylephrine “the power of placebo and the power of the other ingredients.”

The FDA committee considered evidence suggesting that phenylephrine itself is no better than a placebo, or a “dummy drug” used to test the effectiveness of something. But there are several angles to the placebo effect, says Rutledge.

“It has been shown time and time again that if you believe something will work, there will be a subjectively measurable benefit,” he noted, adding that patient outcomes and follow-up treatments are better when patients believe what their doctors tell them.

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Alternatives to oral decongestants

Nasal sprays containing phenylephrine are still considered effective decongestants, Woodcock said, because it goes straight to the source of congestion and is better absorbed by the body. They may also contain oxymetazoline. But nasal sprays have a “major caveat,” she said. That’s possible Only use the spray for a few days, otherwise you risk “rebound congestion”.“That is difficult to get rid of and can last for a year.

And if you want an oral decongestant that works, Rutledge said, ask for the pseudoephedrine. Just side effects may include shakiness or restlessness.

For congestion caused by allergies, you’ll need to target your symptoms a little differently, says Rutledge. A nasally inhaled steroid like Flonase is better for long-term use by people with allergies because “instead of treating the symptoms, the steroid actually blocks the immune response in the nose,” he said.

Antihistamines are also used by people with allergies, but know that antihistamines are not decongestants, Rutledge said. They work by blocking the effect of histamine, which is released by your body in response to an allergy. This is why a simple test to help you find out if you have allergies or a virus is to see if your symptoms improve when you take an antihistamine.

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