top of page
  • Writer's pictureDiego Smith

A Widely Used Over-the-Counter Decongestant May Face Removal From Shelves Due to Ineffectiveness

The future of a common ingredient found in over-the-counter cold and cough medicines is now in question. The Food and Drug Administration (FDA) is on the verge of making a critical decision regarding oral phenylephrine's continued presence in non-prescription nasal decongestant medications. This week, external experts will convene to discuss this issue and offer their recommendations. However, FDA scientists have already made their stance clear, asserting that oral phenylephrine's effectiveness is virtually nonexistent.

The FDA is currently hosting an advisory committee meeting focused on non-prescription drugs, and one of the key subjects under scrutiny is whether oral phenylephrine should be withdrawn from the market as a nasal decongestant. This ingredient is commonly found in numerous cold and allergy medicine brands, including Sudafed PE and certain Nyquil formulations. The primary point of contention revolves around whether phenylephrine should retain its current classification as "Generally Recognized as Safe and Effective" (GRASE).

Ahead of this meeting, the FDA's own researchers published their findings in a report released last Thursday. This is not the first time this issue has been debated; a similar discussion took place in 2007. Back then, despite some initial evidence suggesting the ineffectiveness of oral phenylephrine, the advisory committee and FDA were persuaded by the overall data and arguments presented by cold medicine manufacturers, leading to the retention of the drug on the market. However, the FDA indicated that it might reconsider this decision in the future as further research emerged. In 2015, researchers from the University of Florida petitioned the FDA to reevaluate oral phenylephrine, ultimately resulting in the current advisory committee meeting.

Since 2007, multiple studies on the topic, including three significant clinical trials, have been conducted. The latest data is considerably more definitive. These large-scale placebo-controlled trials have failed to provide any evidence that oral phenylephrine, even when administered in standard or higher doses, effectively relieves nasal congestion. While the drug may exhibit decongestant properties when applied intranasally, recent FDA findings suggest that our bodies barely absorb it when taken orally. In essence, it appears that no reasonable over-the-counter dosage of oral phenylephrine is likely to alleviate a stuffy nose. Furthermore, FDA scientists have pointed out that certain positive studies on the drug in the past suffered from glaring methodological flaws and biases.

In summary, the FDA's reviewers have firmly stated, "We believe that these new clinical pharmacology and clinical data are consistent, substantial, and believable, and they confirm that orally administered [phenylephrine] is not effective at any dose that can be developed and still provide a reasonable margin of safety." The future of oral phenylephrine as a nasal decongestant now hangs in the balance.

bottom of page