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Last week, a panel of U.S. experts determined a decongestant used in many popular over-the-counter medications — including Nyquil, Tyenol Sinus and Advil Sinus in the U.S. — doesn't actually relieve a stuffy nose.
The U.S. Food and Drug Administration (FDA) saw outside experts vote unanimously that phenylephrine is ineffective when taken in pill form, though it's still considered effective in nasal spray.
Phenylephrine is the main ingredient in many decongestants in the U.S. It became popular after the FDA restricted another decongestant, pseudoephedrine, because it can be used in large quantities to make methamphetamine.
A 2007 review of phenylephrine found "insufficient evidence that oral phenylephrine is effective for nonprescription use as a decongestant," and called on the FDA for further studies. But the drug remained on the market.
What are Canadian officials doing about it?
Pseudoephedrine, restricted in the U.S., is still available in Canada in combination with other ingredients, in some Tylenol and Advil products. Phenylephrine is also found in many decongestants in the country, such as in Nyquil.
According to The Canadian Press, federal agency Health Canada has said it will review the FDA experts' declaration that phenylephrine does not get rid of sinus congestion.
"Health Canada said Friday that, following a review, it will take any necessary action to ensure Canadians have access to safe and effective products," the CP wrote.
Decision not a surprise
"Phenylephrine is not considered to be that potent... This is a very classic tale where you have drugs that have been approved since the '60s and '70s, and we're kind of just revisiting them now with the lens of data and analysis that we didn't use back then," Mina Tadrous, an assistant professor of pharmacy at the University of Toronto, told the CBC.
Manufacturers said it's effective
"Oral phenylephrine has been relied upon as a beneficial nasal decongestant by American families for decades, and FDA has repeatedly concluded the ingredient is safe and effective...
"This determination, established by multiple double-blind, placebo-controlled trials and supported by two previous FDA advisory panels, has also been validated by a meta-analysis of relevant clinical studies," read a Sept. 11 statement from the Consumer Healthcare Products Association (CHPA), which represents drug manufacturers.
Nasal spray still works
Mina Tadrous, an assistant professor of pharmacy at the University of Toronto, told CTV, "the advisers believe the oral phenylephrine products may be ineffective because they are metabolized too quickly in the liver.
"The nasal spray works. You're sending it to the place where you need help. If you take a pill it gets absorbed and then it passes by the liver and then it goes up to your nose."
Should have been removed earlier
"This drug and this oral dose should have been removed from the market a long time ago... The patient community requires and deserves medications that treat their symptoms, safely and effectively, and I don’t believe that this medication does that," panel member Jennifer Schwartzott, and a patient representative from New York, said at the vote in front of the FDA.
Lawsuits against drug makers
"Pharmacists affiliated with the University of Florida have spent decades nudging the agency to pull a decongestant from over-the-counter medicines...
"Prompted by the news, consumers threw open their medicine cabinets upon learning that the decongestant, phenylephrine, was listed in more than 250 of their go-to drugs for congestion like some versions of DayQuil, Sudafed, Tylenol and Theraflu. And the decision has caused some confusion — experts say the ingredient still works in nasal sprays, just not when taken orally in pill or liquid form...
"Lawyers representing people who purchased cold and flu medicines containing phenylephrine are already announcing lawsuits against the drug makers, claiming the companies knew the decongestant was useless," wrote investigative journalist Christina Jewett for The New York Times.