A panel of experts in the U.S. has determined that a decongestant found in many popular over-the-counter medications there and in Canada does nothing to relieve nasal congestion.
On Tuesday, advisors to the Food and Drug Administration (FDA) voted unanimously that phenylephrine is ineffective.
Here’s a breakdown of that decision and what it could mean in Canada.
What happened?
An independent FDA panel determined that phenylephrine was ineffective when taken in pill form.
Experts found that when taken in pill form, only small amounts of the drug reach the nasal passages to relieve congestion, making it ineffective.
The drug appears to work best when applied directly to the nose, either through sprays or drops, and those products are not under review in the US.
If it doesn’t work, how did it get so popular?
Phenylephrine became the main ingredient in over-the-counter decongestants in the United States after pseudoephedrine, another drug, was restricted because it can be used to make methamphetamine.
Phenylephrine is also found in many decongestants in Canada, including Nyquil, although pseudoephedrine is still found in others, such as Sudafed.
Through the yearsNumerous studies have questioned the benefits of phenylephrine and trials have not found it to be better than a placebo.
The FDA advisory panel questioned the drug’s effectiveness in 2007, but the regulator allowed the products to remain on the market pending additional research.
What do the Canadian experts say?
Mina Tadrous, assistant professor of pharmacy at the University of Toronto, says the panel’s decision was not a surprise.
“Phenylephrine is not considered to be that potent,” he said.
“This is a very classic story where there are drugs that have been approved since the ’60s and ’70s, and now we’re reviewing them through the lens of data and analytics that we didn’t use back then.”
The Canadian Pediatric Society questioned the use of phenylephrine in 2011. Dr. Michael Rieder was a co-author a declaration outlining the group’s position at that time.
“Our statement basically said, ‘Common cold medicines don’t work, don’t use them,'” said Rieder, a professor of pediatric clinical pharmacology at Western University in London, Ont.
“There is no evidence that they work at all.”
Phenylephrine carries minimal risk, but such cold medications, he noted, can, of course, be expensive.
Rieder says there is also little evidence that pseudoephedrine is effective when taken orally.
He notes that decongestants also often contain paracetamol, which can help relieve the discomfort that accompanies a cold. He recommends taking acetaminophen alone or another pain reliever such as ibuprofen to relieve pain.
If this medicine doesn’t work, what does?
Given the wide range of options available, Tadrous recommends seeking help from your pharmacist.
“The first person you should talk to is your pharmacist and ask, ‘This is how I feel, these are my symptoms. What is the best product for me?'”
Rieder, for her part, recommends that people avoid over-the-counter cough and cold medications altogether and instead stay hydrated and get rest. A teaspoon of honey at night (for those older than one year) a few times a day can also help, he says.
“We’re in a time where people are less likely to hold on,” he said. “A lot of these things just have to run their course.”
Whats Next?
In the United States, Tuesday’s panel vote is unlikely to have any immediate impact, according to The Associated Press.
The drug could eventually be pulled from store shelves, but that would require the FDA to update what is allowed in over-the-counter medications.
Health Canada, which regulates drugs here, had no immediate comment.
