The Phenylephrine Paradox: Ineffectiveness, Steady Sales, and Potential Supply Chain Disruption
The sales of the most commonly used over-the-counter (OTC) oral decongestant, phenylephrine, remained steady through 2021, despite being deemed ineffective by the FDA. This paradoxical trend has sparked concern among health experts and prompted a deeper investigation into the matter.
The Phenylephrine Conundrum
Over the past decade, phenylephrine has been the most popular oral decongestant in the United States, with stable sales from 2012 to 2021. Interestingly, these sales trends persisted despite mounting evidence suggesting the ineffectiveness of oral phenylephrine. The FDA’s advisory committee even went as far as recommending the removal of oral phenylephrine from its OTC monograph, a move that could potentially disrupt the supply chain due to the required reformulation of products.
Phenylephrine Vs. Pseudoephedrine
A cross-sectional study revealed that products containing phenylephrine outpaced those with pseudoephedrine, another common decongestant. Despite the lack of clinical efficacy evidence, phenylephrine products continued to dominate the market. This was largely due to the fact that most phenylephrine products were co-formulated with antihistamines or antitussives, providing symptom relief for cough and cold symptoms.
Impact on Supply Chain
If the FDA decides to remove phenylephrine from the market, it could lead to significant disruption in the drug supply chain. The removal of phenylephrine would also mean the removal of multi-symptom products, potentially leading to shortages. Researchers found a decline in phenylephrine sales, but the FDA is still requesting public comment before making any decision.
Proactive Steps by CVS Health
Recognizing the concerns raised about the effectiveness of phenylephrine, CVS Health announced the voluntary removal of cold medications containing phenylephrine from its shelves. This move signifies the first step towards aligning retail practices with scientific evidence and regulatory guidance.
Need for Reform
The continued sales of phenylephrine despite the lack of efficacy evidence highlight the need for ongoing reform of the nonprescription drug review process. There is a clear need for more stringent regulation and review of OTC medications, with a focus on balancing consumer demand, clinical efficacy, and supply chain stability.
As the FDA continues to gather public comments and consider the potential impact of removing phenylephrine from the market, it’s important for consumers to stay informed. In the meantime, physicians and pharmacists can play a critical role in guiding patients towards evidence-based treatments for common cold and cough symptoms.