FDA admits phenylephrine decongestant doesn't work—what now?

In recent months, the Food and Drug Administration in the United States has begun taking steps to revoke the approval of phenylephrine, a common ingredient found in many over-the-counter cold and allergy treatments, notably Sudafed and Dayquil. Concerns regarding the effectiveness of phenylephrine have been raised over several years, particularly from researchers at the University of Florida who initially petitioned the FDA to reevaluate its use in both 2007 and 2015. Following a series of studies, evidence suggested that even higher doses of phenylephrine were ineffective in treating nasal congestion, leading to a formal proposal by the FDA last month to phase out its usage in oral pills and liquid formulations. As part of the FDA's initiative, the agency will be accepting public comments for the next six months regarding this proposal. If finalized, drug manufacturers would have an additional year or more to reformulate their products, which may lead to a significant shift in the over-the-counter medications available to consumers. Major companies like Johnson & Johnson and Bayer have anticipated this shift and have already begun modifying their products, labeling many as “PE” versions, which denotes they contain phenylephrine but may not be effective. Consequently, consumers may need to seek alternative options for congestion relief. The FDA's proposal has unearthed a broader discussion about the efficacy and safety of medications widely used by the public. The release of an alternative decongestant, pseudoephedrine, which is available behind pharmacy counters, has reignited debates among healthcare professionals and consumers alike. Pseudoephedrine remains accessible but does require a photo ID for purchase due to regulations aimed at preventing its misuse. Additionally, non-drug options such as saline drops and antihistamine nasal sprays have been highlighted as effective alternatives, leading to recommendations for patients to consider these methods instead. Ultimately, the decision to phase out phenylephrine could reshape how consumers manage nasal congestion and cold symptoms in the future. As the FDA navigates public feedback and prepares for potential changes in the market, the ongoing conversation highlights the importance of ensuring that medications available meet efficacy standards for the well-being of patients. Research and regulations may continue to evolve as effectiveness remains a focal point within the healthcare industry.