In early September 2023, the U.S. Food and Drug Administration (FDA) advisors voted unanimously against the effectiveness of the popular drug phenylephrine, found in Sudafed, Dayquil, and similar medicines.
Sudafed and Dayquil are used to combat allergies, targeting nasal congestion.
According to the FDA’s advisors, the drug phenylephrine does not work against allergies and congestion. They are recommending stores to remove drugs containing phenylephrine from shelves.
Sudafed and other medicines in the same drug class were tested for effectiveness in 2007. The FDA’s advisors also recommended that the drugs be removed from shelves; however, the FDA allowed the products to remain on the market.
Patient representative Jennifer Schwartzott was among the advisors recommending that phenylephrine should be removed from shelves. “Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that,” Schwartzott said.
The advisors’ conclusions were backed by an FDA scientific review published before the advisors’ meeting. The scientific review covered numerous flaws in the 1960s and 1970s studies that originally supported phenylephrine’s approval. According to regulators, the studies were “extremely small” and used statistical and research techniques that are no longer accepted by the agency.
The FDA’s advisors said that removing drugs with phenylephrine would remove “unnecessary costs and delay in care of taking a drug that has no benefit.”
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