The Food and Drug Administration (FDA) in the United States recently declared that oral phenylephrine, a common ingredient in many cold and cough medications, is ineffective. This has led to a proposed removal of phenylephrine from over-the-counter medications used for nasal congestion relief. While the U.S. debates this decision, many are questioning whether Canada will follow suit. Health Canada is currently reviewing the information to determine if similar action is necessary, as the decongestant remains available in Canada. Last year, the FDA’s outside advisers unanimously agreed that orally administered phenylephrine is not effective as a nasal decongestant.
The move to remove phenylephrine from over-the-counter medications in the U.S. stemmed from a 2006 law that restricted access to pseudoephedrine, a previous decongestant that could be used to produce methamphetamine. The Consumer Healthcare Products Association, an American trade association, expressed disappointment with the FDA proposal, citing years of reliance on oral phenylephrine for nasal congestion relief. However, the effectiveness of oral phenylephrine has been called into question due to its limited absorption in the bloodstream, making it less effective compared to nasal sprays containing the ingredient. While oral cold medications containing phenylephrine may provide some relief due to combined ingredients or the placebo effect, they are not as effective in targeting congestion directly.
In Canada, phenylephrine is approved for use as an oral decongestant, and Health Canada is currently evaluating the situation following the FDA’s advisory committee conclusion on the ineffectiveness of oral phenylephrine. The Food, Health and Consumer Products of Canada (FHCP) has stated that its members will work with Health Canada to ensure self-care options for cold and flu season remain available for Canadians. While the FDA’s proposal to remove oral phenylephrine is pending a final ruling, drug manufacturers would need to comply with the decision and remove products containing the ingredient from store shelves if the order is finalized.
Dr. Michael Rieder, a pediatric clinical pharmacologist and professor, explained that oral phenylephrine works by increasing blood flow to clear congestion but is most effective when applied directly to the affected area. The limitation of absorption in the bloodstream hinders the effectiveness of oral phenylephrine, leading to the FDA’s proposal for its removal. During cold and flu season, Rieder recommends acetaminophen for aches, antihistamines for congestion, and honey for cough relief as effective alternatives. The reasoning behind the FDA’s move to remove phenylephrine is to ensure that over-the-counter medications are safe and effective for consumers, with a focus on providing relief for nasal congestion using more efficient methods.
The availability of oral phenylephrine in over-the-counter medications in Canada is currently under scrutiny, with Health Canada considering the advisory committee’s findings and potentially taking action if necessary. The focus is on ensuring that Canadians have access to safe and effective health products during cold and flu season. The discussion around the effectiveness of oral phenylephrine highlights the importance of regulatory oversight in the approval and continued use of active ingredients in over-the-counter medications. As the debate continues in both the U.S. and Canada, the emphasis remains on providing consumers with reliable alternatives for cold and cough relief without compromising safety and effectiveness.
