An advisory panel to the Food and Drug Administration (FDA) has declared that the main ingredient, phenylephrine, used in many popular over-the-counter cold and allergy medications, doesn’t effectively relieve nasal congestion. In a unanimous vote, 16 advisors concluded that oral forms of phenylephrine found in medications like Nyquil, Benadryl, Sudafed, and Mucinex are not effective in treating a stuffy nose.
While the FDA typically follows the advice of its advisory committees, it is not obligated to do so. The agency may initiate a process to remove phenylephrine from the market, which would require manufacturers to reformulate widely used cough and cold medications and remove them from store shelves.
Companies like Procter & Gamble, which manufactures Nyquil, and Johnson & Johnson subsidiary Kenvue, responsible for Tylenol and Benadryl products, could be affected by such a move.
The Consumer Healthcare Products Association, representing OTC drug manufacturers and distributors, expressed disappointment with the advisory panel’s vote and encouraged the FDA to consider the evidence supporting phenylephrine’s use.
Phenylephrine is a commonly used decongestant in oral cold and allergy medications, and retail pharmacy chains generate significant revenue from selling these products. In 2021, U.S. retail stores sold 242 million bottles of drugs containing phenylephrine, generating $1.8 billion in sales.
Without oral phenylephrine, patients may need to turn to liquid or spray versions of the drug or seek alternative medications. The advisory panel meeting was initiated by researchers at the University of Florida, who petitioned the FDA based on studies showing that phenylephrine products failed to outperform placebos in relieving congestion.
The FDA staff, in briefing documents ahead of the meeting, concluded that oral formulations of phenylephrine are not effective at standard or higher doses, as only a minimal amount of the drug reaches the nose to relieve congestion.
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