Feeling stuffy and ready to reach for NyQuil, Benadryl, or Sudafed PE?
Not so fast.
The Food and Drug Administration (FDA) has proposed ending the use of oral phenylephrine, a common ingredient found in many cold and allergy medicines — and some pharmacies already are yanking the popular products off shelves.
Florida researchers have been studying the effectiveness of oral phenylephrine for two decades. As far back as 2005, researchers at the University of Florida College of Pharmacy had suspected that this ingredient doesn’t relieve nasal congestion, even though it has been widely used for that purpose. The researchers evaluated multiple studies done on oral phenylephrine and combined them into a meta-analysis. They concluded that medications with the ingredient work no better than placebo pills in patients with cold and allergy congestion.
“For 20 years, we have been telling everyone who will listen that oral phenylephrine doesn’t work,” said Dr. Randy Hatton, a University of Florida College of Pharmacy professor. “We have been teaching pharmacy students that it doesn’t work. We hear from pharmacists who know it doesn’t work. And we actually did something about it.”
Hatton and UF professor, Dr. Leslie Hendeles, took their findings to the FDA, more than once. Finally, in September 2023, the federal agency convened a committee and issued a proposed order.
“They looked at all the evidence we looked at and did an in-depth evaluation of what we had been looking at for years,” Hatton said.
The FDA is allowing the public to comment for the next six months before it decides whether to pull medications with oral phenylephrine from shelves. But some retail pharmacies aren’t waiting. CVS stopped selling products with phenylephrine last year. Other major pharmacies, including Walgreens and Rite Aid, still stock products containing the drug, but say they are monitoring the FDA’s actions.
So, what are some options for Floridians suffering from congestion without their go-to medicines?
Hatton said nasal sprays with phenylephrine are an option.
“In spray form, phenylephrine causes nasal constriction and opens up passages,” he said. “But only use the sprays for three to five days. People who keep taking them get rebound congestion.”
Doctors and pharmacists also recommend other options:
Intranasal steroids like Flonase and Nasonex, or over-the-counter nasal sprays with oxymetazoline such as Afrin and Zicam
Saline irrigation devices, like a neti pot, that help wash sinuses out (but only use distilled water, not tap)
Nasal saline sprays, like Sinex or Simply Saline, which also use a saltwater solution to irrigate sinuses
Products with pseudoephedrine, the ingredient in Sudafed, which can be found behind the pharmacy counter
Oral antihistamines like Zyrtec, Allegra and Claritin, which clear nasal congestion associated with allergies
“If you have questions, talk to the pharmacists. They are trained in nonprescription drugs. Just ask, does this work for congestion?” Hatton advises.
Those seeking non-medication options may try:
Spicy foods, which can create a burning sensation from a chemical called capsaicin, causing a runny nose that drains mucus from sinuses
Steam from a hot shower or a warm compress placed over the nose
Humidifiers
Got health ideas, tips or comments? South Florida Sun Sentinel health reporter Cindy Goodman can be reached at cgoodman@sunsentinel.com.
