Updated Sep 12, 2023 - Health

FDA panel deems ingredient in common cold medications as ineffective

Cold and flu medicine sits on a store shelf on Sept. 12 in Miami, Florida. Photo by Joe Raedle/Getty Images

A Food and Drug Administration advisory panel unanimously agreed Tuesday that an ingredient in commonly used decongestants is ineffective and should be reclassified.

The big picture: The agency will now consider whether to revoke the safety designation of oral formulations of phenylephrine, which is in drugs like Sudafed PE and some versions of NyQuil.

  • The FDA review raises potentially big implications for the over-the-counter drug market along with questions about whether popular cold remedies will be pulled from shelves.

By the numbers: The decongestant is in some 250 products worth nearly $1.8 billion in sales last year, the New York Times reports.

Of note: The FDA usually follows the advice of independent advisory committees, but it is not required to.

What they're saying: "I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug," panel chairperson Maria Coyle, associate professor of pharmacy at Ohio State University, said per the Times.

Zoom in: The FDA said it's been monitoring the ingredient since the agency last reviewed it in 2007, Axios' Jason Millman reports.

  • Since then, there have been three large trials of oral phenylephrine the FDA described as "by far the largest and most carefully conducted trials" of the ingredient ever conducted.
  • The trials "confirm that orally administered PE is not effective at any dose that can be developed and still provide a reasonable margin of safety," the agency said.

Worth noting: The FDA said it hasn't identified any safety issues with the ingredient, but rather is concerned about possible unintended consequences of revoking over-the-counter status.

  • "This is a shame," Scott Gottlieb, former FDA commissioner and a Pfizer board member, tweeted on Tuesday. "Now cold sufferers may have even fewer accessible options, driving up healthcare costs."
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