A U.S. drug advisory panel has unanimously questioned the effectiveness of phenylephrine, a common decongestant in over-the-counter cold medications like Sudafed. If the FDA follows their recommendation, pharmaceutical companies might have to remove these products from store shelves. The panel cited concerns about phenylephrine’s safety at higher doses and emphasized its ineffectiveness. This move may encourage consumers to opt for alternative options or behind-the-counter medications. The FDA’s streamlined process may speed up the removal of phenylephrine from approved decongestants in nonprescription products.
A U.S. drug advisory panel has cast doubt on the effectiveness of a popular decongestant found in many over-the-counter cold medications, potentially leading to its removal from store shelves. The drug in question, phenylephrine, has long been a key ingredient in well-known products like Sudafed and Dayquil. However, experts convened by the U.S. Food and Drug Administration (FDA) recently voted unanimously against its efficacy in providing relief from nasal congestion.
Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, emphasized that modern research fails to demonstrate any significant improvement in congestion when using phenylephrine.
The FDA’s interest in phenylephrine stems from a legislative change in 2006, which led to the removal of pseudoephedrine, an older ingredient, from over-the-counter decongestants due to its potential use in illegal drug production. As a result, phenylephrine became the primary decongestant ingredient in these medications.
Should the FDA follow the panel’s recommendations, it could require pharmaceutical companies like Johnson & Johnson and Bayer to withdraw their oral products containing phenylephrine from the market. This move might prompt consumers to switch to behind-the-counter pseudoephedrine options or phenylephrine-based nasal sprays and drops.
The panel raised concerns about the safety of studying phenylephrine at higher doses, as it could potentially elevate blood pressure to dangerous levels. Dr. Paul Pisaric of Archwell Health in Oklahoma stated, “I think this is a done deal as far as I’m concerned. It doesn’t work.”
In Canada, the Canadian Paediatric Society had previously highlighted the ineffectiveness of cold and cough medications containing phenylephrine. Dr. Michael Rieder recommended parents opt for alternative remedies, such as fluids, acetaminophen (Tylenol), and pasteurized honey for children, as they can be more effective and safer.
The recent advisory panel meeting was prompted by University of Florida researchers who petitioned the FDA to reconsider phenylephrine products based on studies showing their ineffectiveness compared to placebo pills in treating congestion. The FDA’s outside experts had previously recommended keeping these products on the market, but this time, the panel unanimously agreed that there is insufficient evidence of their benefit.
The panel’s opinion opens the door for the FDA to remove phenylephrine from the list of approved decongestants for over-the-counter medications, eliminating unnecessary costs and delays in patient care. The FDA is now positioned to expedite the publication of new standards for nonprescription ingredients, thanks to a 2020 law passed by Congress, potentially streamlining the process of updating the nasal decongestants drug list.