FDA Panel Reveals: Deconstructing the Ineffectiveness of Common Cold Medicines’ Decongestant

Phenylephrine, a widely used ingredient in many over-the-counter cold medicines, has been deemed ineffective as a decongestant when taken orally. In fact, it is no more effective than a placebo, according to an independent advisory committee to the U.S. Food and Drug Administration (FDA) that voted unanimously on Tuesday.

The panel’s conclusion raises questions about the use of phenylephrine in popular products like Sudafed, Mucinex, Benadryl, and Vicks. If the FDA agrees with the committee’s findings, it may decide to remove these medications from store shelves.

Committee member Jennifer Schwartzott, a patient representative from New York, expressed her belief that phenylephrine should have been taken off the market long ago. She emphasized the need for medications that effectively and safely treat patients’ symptoms.

The committee’s decision was based on a scientific review conducted by the FDA regarding phenylephrine’s effectiveness. The panel members concluded that there was no need for additional data or studies to prove the inefficacy of phenylephrine. It is worth noting that this drug was approved decades ago and did not undergo the same rigorous testing standards as current medications.

During the discussion on the potential financial impacts of removing phenylephrine products from the market, committee members emphasized the importance of prioritizing patient safety.

Diane Ginsburg, an associate dean for Healthcare Partnerships at the University of Texas at Austin College of Pharmacy, stated that patient safety should always take precedence over financial considerations.

Maryann Amirshahi, a medical toxicologist at the National Capital Poison Center and another committee member, recommended that the FDA provide guidance to consumers on what to do with oral medications containing phenylephrine. She also highlighted the need for consumers to be informed about alternative products.

Amirshahi emphasized that the issue with phenylephrine is more related to its efficacy rather than safety. The potential harms of continued use include unnecessary costs, delayed medical treatment, increased drug consumption without relief, and potential allergic reactions, as outlined in the FDA’s review.

The review further acknowledged that some consumers may not want to stop using phenylephrine. This could be due to a preference for oral medications or a lack of knowledge about obtaining pseudoephedrine, which is a decongestant sold behind the counter due to its misuse in making methamphetamine. It is also possible that some individuals believe phenylephrine provides relief despite the committee’s findings, leading to frustration or a switch to other treatments with their own risks and limitations.

This story has been updated to clarify that not all Sudafed, Mucinex, Benadryl, and Vicks products contain phenylephrine.