In response to a recent announcement by American health specialists suggesting that a key component in common over-the-counter (OTC) cold and allergy medications has no impact on alleviating nasal and sinus congestion, Health Canada has initiated a comprehensive review. The component in question, phenylephrine, an orally administered decongestant, has been unanimously debunked for its effectiveness by advisers to the U.S. Food and Drug Administration (FDA).
Medications such as Sudafed and DayQuil, which contain phenylephrine, might soon no longer carry the label of over-the-counter; this implies a potential dismissal from retail shelves. However, the FDA has not yet finalized its decision concerning this reclassification.
Subsequent to a 2006 law in the U.S. prohibiting over-the-counter sales of products containing pseudoephedrine—a different type of decongestant that can be used to produce methamphetamine in large quantities—phenylephrine gained popularity as a substitute in cold and allergy medicines. However, medications with pseudoephedrine are now retained behind pharmacy counters.
On Friday, Health Canada expressed its commitment to guaranteeing the distribution of safe and effective health products to its citizens, promising to undertake any essential measures following the review of the phenylephrine situation.
Despite phenylephrine also being available in nasal sprays, multiple studies have called into question the compound’s efficacy. Nonetheless, the FDA clarified that its advisory committee’s recent vote only pertains to oral phenylephrine and does not encompass its nasal spray counterpart.
Mina Tadrous, an assistant pharmacy professor at the University of Toronto, explained that the oral version of phenylephrine might be ineffective due to its quick metabolism in the liver. He implied that the nasal spray variant could potentially be more effective by targeting the areas requiring relief more directly.
While Canadian consumers can still find pseudoephedrine in select over-the-counter Tylenol and Advil products, Tadrous suggests consulting with a pharmacist for symptom-specific advice. He regards phenylephrine as an example of a drug approved in the late 1960s on the basis of “slight evidence” of its functionality as a decongestant, emphasizing that safety predominated regulators’ concerns at the time.
The FDA recently assured the public that its advisory committee had identified no safety risks associated with the recommended dosage of oral phenylephrine. Tadrous, however, pointed out the challenge presented when determining the necessity of reevaluation for older ingredients that have so far exhibited no safety concerns. He noted that countless medications have been reexamined for efficacy over time through resource-limited, lengthy processes.
