The main ingredient in popular over-the-counter decongestants found in pharmacy aisles under familiar brands like Sudafed PE, Vicks DayQuil, Theraflu and others isn’t effective, according to advisers to the Food and Drug Administration.
After a two-day meeting, the panel of 16 experts unanimously concluded on Sept. 12 that the popular drug phenylephrine works no better than a placebo pill.
What is phenylephrine?
Phenylephrine is an over-the-counter drug that has been used for decades to relieve congestion and stuffy nose caused by allergies or colds, and purportedly works by reducing the swelling of blood vessels in the nasal passages.
The FDA advisory panel concluded that oral forms of phenylephrine are ineffective, but nasal sprays and drops containing phenylephrine weren’t under review and are still considered effective.
Phenylephrine has been available for so long — what changed?
In 2007, researchers at the University of Florida questioned the efficacy of phenylephrine decades after it had been "legacied" in for approval by an FDA review begun in 1972, but the FDA allowed it to stay on the market pending additional research. Those same University of Florida researchers again urged the FDA to remove phenylephrine products from shelves after recent studies showed they were no better than placebos at treating cold and allergy congestion.
“A lot of things have changed since 2007,” Dr. Zara Patel of Stanford Medicine, tells Yahoo Life. “Science has improved, the way in which we study medications has improved and even the outcome measures that we use to determine whether nasal congestion is getting better have improved.”
She adds that people shouldn’t be upset by this new update.
“This is just how science works. That’s the beauty of science — we can gather more, new, better data and allow that data to change our minds about something.”
Experts Yahoo Life spoke with said they weren’t surprised — and that many clinicians already avoided recommending phenylephrine to patients.
“We've known that for a long time,” Dr. J. Routt Reigart, chair of the American Academy of Pediatrics committee on drugs tells Yahoo Life. “Most pediatricians do not intentionally prescribe phenylephrine-containing remedies.”
Why doesn’t it work?
When taken in oral form, phenylephrine is metabolized pretty quickly, so the amount that’s absorbed into the bloodstream ends up being less than 1% of what was originally ingested — which is not enough to be effective, experts concluded.
But if you’ve used phenylephrine at the recommended dosage in the past, you don’t need to worry. FDA advisers didn’t flag any new side effects or dangers when taken as directed.
“It’s not that anyone was put at risk, it’s just that it’s not effective,” Patel says. “I would say it’s more a waste of time [and] a waste of money.”
Why does phenylephrine seem to work for me?
If oral phenylephrine has been your go-to for congestion relief, you may be confused by news that it’s actually no better than a dummy pill. Experts say there could be some placebo effect at play — with patients experiencing some relief because of their belief in the power of the pill.
Patel says that if medications containing phenylephrine have helped you feel better in the past, it may have more to do with the other ingredients involved.
“Most of the time phenylephrine is being combined with other medications that help with other symptoms that people get with a cold or with allergies,” she says. “Any of your typical cold and sinus over the counter meds or allergy over the counter meds, they won't just have phenylephrine in them. They have phenylephrine plus maybe some mucus thinning medication, maybe some expectorant medication to help with coughing or a cough suppressant. There’s so many different types of medications that are typically combined in these generalized cold pills or allergy pills, and that really may be why they do feel some benefit.”
It’s also possible that some people may have experienced some benefit from oral phenylephrine medications, but FDA advisers concluded that simply wasn’t the case for a majority of people.
“When we talk about safety and efficacy, we’re looking at averages,” Patel explains. “There are some people that are much more sensitive to medications, so it is possible that some people will have some effect at a lower dose than others. When we say something’s not effective, that means the majority of people that took that medicine did not find benefit. It doesn’t mean that a few people may not have.”
What happens next and what should I use instead?
If the FDA decides to follow the advisory panel’s recommendations, drugmakers may be required to remove oral phenylephrine medications from store shelves. But that process would likely take awhile, so we shouldn’t expect to see any immediate impact from the panel’s decision.
"Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision," the FDA said in a statement on Sept. 14. "FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine."
In the meantime, experts say there are plenty of options.
“There’s so many other products out there that really do work,” Dr. James Tracy, vice president of the American College of Allergy, Asthma and Immunology, tells Yahoo Life. “Almost all the nasal sprays, like nasal antihistamine sprays, they all work and they are also over-the-counter, but they don’t say ‘decongestant.’”
Pseudoephedrine is the most common oral decongestant alternative, but since it has potential for abuse, you’ll likely need to ask a pharmacist for help accessing it behind the counter. Some states also have limits per family on how much you can purchase, or may require you to show some form of ID.
In addition to topical steroid sprays and topical antihistamine sprays, which are safe and effective, phenylephrine is also still considered effective in nasal spray form — though Tracy warns it can be “habit-forming” if used regularly.
“You should only use those for two to three days at the most,” he says of phenylephrine nasal sprays. “There can be, definitely, a side effect of something we refer to as ‘rebound congestion’ [if overused], but they definitely work.”
For children suffering from allergies, Reigart says saline nose drops or first generation antihistamines such as Benadryl can be beneficial for congestion. But oftentimes, you can skip the meds.
“My recommendation for the usual cold or runny nose, if it’s not allergic, would be not to use anything,” Reigart says.