THE FDA has announced it is proposing removing oral phenylephrine from the list of over-the-counter (OTC) nasal decongestant ingredients due to extensive evidence questioning its effectiveness. This recommendation, based on comprehensive scientific review, aligns with the growing consensus among healthcare experts that oral phenylephrine does not provide sufficient nasal decongestion relief, despite its longstanding use in OTC cold and allergy medications.
The announcement follows a detailed examination of clinical studies, revealing that oral phenylephrine has limited, if any, efficacy when used in typical OTC dosages. For decades, phenylephrine has been marketed as a safe and accessible option for nasal congestion relief. However, recent analyses suggest that its oral formulation does not achieve necessary concentrations in nasal passages to deliver meaningful decongestant effects.
While phenylephrine is still considered effective when administered topically, such as in nasal sprays, the FDA has expressed concern over its oral form’s limited performance. This aligns with the recommendations of the Nonprescription Drugs Advisory Committee, which recently concluded that oral phenylephrine’s benefits were marginal compared to its widespread use.
For healthcare providers, the FDA’s proposal signals a shift in OTC cold and allergy treatment. Medical professionals may need to explore alternative decongestants for patients, particularly those relying on oral phenylephrine. Should the proposal be enacted, manufacturers may need to reformulate existing products, and clinicians might need to inform patients about different effective options for symptom relief.
The FDA has opened a public comment period for healthcare professionals and stakeholders to discuss the proposal before issuing a final decision. If approved, the ruling could reshape OTC treatment options and further emphasizes the importance of evidence-based medicine in consumer healthcare products.
Reference: FDA. FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. November 7, 2024. Available at: https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after. Last accessed: November 7, 2024.
Anaya Malik | AMJ
