The main ingredient in the popular over-the-counter decongestants found in pharmacy aisles under familiar brands, including Vicks DayQuil and Sudafed PE, Theraflu, and others, isn’t effective, according to Food and Drug Administration advisers.
Following a two-day meeting, the panel of 16 experts unanimously concluded on September 12 that phenylephrine does not work better than a placebo pill.
What is phenylephrine?
Phenylephrine is an over-the-counter drug used for decades to relieve stuffy nose and congestion caused by colds or allergies 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 drops and nasal sprays containing phenylephrine weren’t under review and are still considered effective.
Phenylephrine has long been available — so what changed?
In 2007, University of Florida researchers questioned the efficacy of phenylephrine decades after it had been “legacied” in for approval by an FDA review that was begun in 1972. However, the FDA allowed it to stay on the market with additional research pending.
The same University of Florida researchers urged the FDA again to remove phenylephrine products from shelves after recent studies showed they weren’t better than placebos at treating allergies and cold congestion.
“A lot of things have changed since 2007,” said Dr. Zara Patel of Stanford Medicine. “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.”
Patel added 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 new, better data and allow that data to change our minds about something.”
Experts said they weren’t surprised and that many clinicians have already not been recommending phenylephrine to patients.
“We’ve known that for a long time,” said the American Academy of Pediatrics committee chair on drugs, Dr. J. Routt Reigart. “Most pediatricians do not intentionally prescribe phenylephrine-containing remedies.”
Why doesn’t it work?
When taken orally, phenylephrine is metabolized rapidly. According to the experts, the amount absorbed into the bloodstream is less than 1% of what was ingested originally — which isn’t enough to be effective.
However, if you’ve used phenylephrine at the recommended dosage in the past, experts said there should be no worry. FDA advisers didn’t flag any new danger or side effects when taken as directed.
“It’s not that anyone was put at risk, it’s just that it’s not effective,” said Patel. “I would say it’s more a waste of time [and] a waste of money.”
Why does it seem to work for me?
If your go-to for congestion relief is oral phenylephrine, you may be confused by the news that it’s no better than a placebo pill. Experts say there may be some placebo effect in play — with patients experiencing some relief because they believed in the medication.
Patel says if medications containing phenylephrine have helped the past to make you feel better, it may be due to other ingredients.
“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,” said Patel. “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. So many different types of medications are typically combined in these generalized cold pills or allergy pills, which may be why they do feel some benefit.”
It is also possible some people may have experienced some benefit from medications like oral phenylephrine, but FDA advisers concluded that wasn’t the case for most people.
“When we talk about safety and efficacy, we’re looking at average,” explains Patel. “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 should I use, and what happens next?
If the FDA decides to follow the advisory panel’s recommendations, drugmakers may be required to remove the oral form of phenylephrine medications from the shelves of stores. But the process would likely take a while, 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,” said the FDA in a September 14 statement. “FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine.”
Meantime, experts say there are several options.
“There’s so many other products out there that really do work,” said Dr. James Tracy, the vice president of the American College of Allergy, Asthma and Immunology. “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 alternative oral decongestant. Still, since it can be abused, you will likely need to ask a pharmacist for assistance accessing it behind the counter. Some states also limit how much you can purchase or may require you to show a form of ID.
In addition to topical antihistamine and topical steroid sprays, which are effective and safe, phenylephrine is also still considered effective in the form of nasal spray — though Tracy warns it can be “habit-forming” if used regularly.
“You should only use those for two to three days at the most,” Tracy said 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.”
According to Reigart, for children suffering from allergies, first-generation antihistamines, and saline nose drops such as Benadryl can be beneficial for congestion. But often, you can skip the medications.
“My recommendation for the usual cold or runny nose, if it’s not allergic, would be not to use anything,” said Reigart.