Health Canada will review a statement from U.S. government experts that a key ingredient in over-the-counter cold and allergy medications, also available in the country, does not work to clear nasal and sinus congestion.
Advisors to the U.S. Food and Drug Administration (FDA) voted unanimously this week against the effectiveness of the orally administered decongestant phenylephrine, found in drugs such as Sudafed and DayQuil.
The FDA still has to decide whether to revoke the over-the-counter designation of drugs containing phenylephrine, meaning they may have to be removed from store shelves.
Phenylephrine became a common ingredient in cold and allergy medications after a 2006 U.S. law banned the over-the-counter sale of products containing another type of decongestant called pseudoephedrine, which can be used to make methamphetamine.
This version is kept behind pharmacy counters.
Health Canada says that following a review, all necessary steps will be taken to ensure Canadians have access to safe and effective products.
Various studies have already questioned the benefits of phenylephrine, which is also available in nasal spray form, although the FDA says its advisory committee’s latest vote only concerns phenylephrine in oral form, not the nasal spray. .
According to University of Toronto assistant professor of pharmacy Mina Tadrous, U.S. advisors have ruled that oral phenylephrine products may be ineffective because they are metabolized too quickly in the liver.
“The nasal spray works because you send it to where the problem is. But if you take a pill, it’s absorbed, then it goes through the liver and then goes up to your nose,” he summarized.
In Canada, pseudoephedrine is still available in combination with other ingredients in some products, such as Tylenol and Advil, over the counter. Mr. Tadrous stressed, however, that it is best to consult a pharmacist about specific symptoms.
He said phenylephrine is an example of a drug approved in the late 1960s with “slight evidence” showing its effectiveness as a decongestant.
The FDA clarified in a statement this week that its advisory committee had not raised any concerns about safety issues related to the use of oral phenylephrine at the recommended dose.
The effectiveness of thousands of drugs has been reassessed over the years in lengthy processes with few resources, but the challenge is deciding which older ingredients should receive the same review if no safety concerns exist. “has been reported,” said Mr. Tadrous.
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