If popular decongestant in NyQuil, Sudafed and other cold medicines doesn't work, what does?

A key ingredient in common over-the-counter oral decongestants and cold medicines doesn’t work, an FDA panel ruled this week, and could be pulled from drugstore shelves.

Phenylephrine — found in some versions of Sudafed, NyQuil and Mucinex — is ineffective as an oral decongestant, the 16 experts advising the U.S. Food and Drug Administration unanimously voted.

Given that sales of products with the ingredient were worth $1.7 billion dollars in 2022, the advisory came as a surprise to plenty of people. The FDA will decide whether or not these medications will remain for sale.

Why has an ineffective drug been for sale on drugstore shelves for so long? And what is the best way to soothe a stuffy nose?

Here is what you need to know.

What works to treat congestion?

Medicines with pseudoephedrine — which are kept behind the pharmacy counter — can be effective, but should only be used on a short-term basis, doctors said.

"Most of the reason people are taking these is for the common cold," said Dr. Erin McGintee, an allergist with ENT and Allergy Associates in Southampton. "Often just drinking fluids, using saline nasal spray, rest and if you have a fever, taking Advil or Tylenol alone, is sufficient rather than loading up on these medications that have multiple different ingredients."

McGintee said nasal sprays like Flonase are a better option for treating nasal congestion than decongestants.

“In the allergy world, we don't really recommend decongestants as a first-line treatment,” McGintee said. “Sometimes these multi-symptom cold medicines have more than you need."

The FDA advisers examined evidence on only oral medications — not nasal sprays — that have phenylephrine.

What can help more serious congestion from allergies?

McGintee said people should consult with their primary care doctor or see an allergist or an ENT specialist to discuss treatment options.

“Topical nasal steroids [such as Flonase] are, in the allergy world, really the first-line for patients whose main symptom is congestion,” McGintee said. “I would never recommend an over-the-counter decongestant. And then it's more about addressing the triggers and trying to figure out what is causing their congestion to begin with."

Why were oral medicines with phenylephrine allowed to be sold for years if they don’t work?

“The whole nature of what is effective — and what isn't — is an ever-improving process,” said Dr. Michael Frohman, chairman of the department of pharmacological sciences at the Renaissance School of Medicine at Stony Brook University. “As science improves, we are able to measure things better and make better predictions about what’s working and what isn’t.”

Phenylephrine was thought to be effective based on best practices decades ago. Since then, standards have tightened, he said.

If you take a pill that includes phenylephrine as a decongestant, it gets into your bloodstream and up into your nose. By that time, there is almost none left, he said.

“The early clinical trials from 30 or 40 years ago showed it was safe and some small-scale studies showed it was effective," McGintee said. "Since that time there have been more rigorous placebo-controlled studies not showing any clinically significant difference.

“It’s not dangerous but the thought was, ‘Why are we making people pay money for something that's not gonna give them any benefit over just taking the antihistamine alone?’ ”

The review of phenylephrine was sparked by researchers at the University of Florida College of Pharmacy who had previously petitioned the FDA to remove it from the market, pointing to updated studies showing it was ineffective.

Why is phenylephrine in so many cold and sinus medicines?

Before 2006, pseudoephedrine was a common ingredient in over-the-counter decongestants and deemed to be more effective.

Because it can be used in the illegal manufacture of methamphetamine, it was banned from store-shelf sales. You can still purchase medicines such as Sudafed with pseudoephedrine, but the law limits the monthly amount any individual can purchase, requires buyers to show photo identification and mandates retailers keep personal information about these customers for at least two years after the purchase of these medicines, according to the FDA.

“A lot of the drug manufacturers wanted to have a different decongestion option to offer patients," McGintee said.

By Lisa L. Colangelo

lisa.colangelo@newsday.com@lisalcolangelo

Lisa joined Newsday as a staff writer in 2019. She previously worked at amNewYork, the New York Daily News and the Asbury Park Press covering politics, government and general assignment.