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This follows an extensive review that found the drug ineffective for treating nasal congestion.
Oral phenylephrine, widely marketed in cold and allergy medications, has been in use for decades as a go-to nasal decongestant.
However, an FDA review, backed by last year’s unanimous recommendation from the Nonprescription Drug Advisory Committee, found that phenylephrine in oral form does not deliver effective congestion relief at recommended dosages.
The FDA emphasized that this proposal is based on effectiveness, not safety concerns.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
The FDA’s findings point to a gap between older data, which once supported oral phenylephrine’s effectiveness, and recent studies that cast doubt on its efficacy.
The agency held a public advisory committee meeting last fall, where scientists reviewed new data and concluded that oral phenylephrine’s impact on nasal congestion is negligible.
Despite the proposed order, over-the-counter products containing oral phenylephrine may remain on shelves for the time being. If the FDA ultimately issues a final order, manufacturers would need to reformulate or withdraw these products from the market.
“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” said Dr. Theresa Michele, director of the Office of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. She advised consumers to consult healthcare professionals about alternatives for congestion relief.
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