FDA Advisors Confirm: Phenylephrine Decongestants Are Ineffective

The main ingredient used in many popular over-the-counter cold and allergy medications does not actually work to alleviate nasal congestion, as declared by an advisory panel to the Food and Drug Administration on Tuesday.

In a unanimous vote, 16 advisors affirmed that oral forms of phenylephrine – a nasal decongestant found in medications like Nyquil, Benadryl, Sudafed, and Mucinex – do not effectively relieve a stuffy nose.

The FDA usually follows the advice of its advisory committees, though it is not obligated to do so. The agency could potentially initiate a process to remove phenylephrine from the market, which would require manufacturers to withdraw widely used cough and cold medications and reformulate their products.

This decision could impact Procter & Gamble, the manufacturer of all versions of Nyquil, and the Johnson & Johnson spinoff Kenvue, which manufactures Tylenol and Benadryl products.

The Consumer Healthcare Products Association, a trade organization representing manufacturers and distributors of OTC drugs, expressed “disappointment” with the advisory panel’s verdict.

“Before making any regulatory determination, we urge the FDA to consider the comprehensive evidence supporting this long-standing OTC ingredient, as well as the significant negative consequences associated with any potential change” to phenylephrine’s regulatory status, commented Scott Melville, the CEO of the organization.

The removal of phenylephrine from the market could also impact retail pharmacy chains, as they generate revenue from the sale of over-the-counter cold and allergy pills.

In the U.S., retail stores sold 242 million bottles of drugs containing phenylephrine last year, a 30% increase from 2021, according to data compiled by FDA staff. These sales generated $1.8 billion in revenue last year.

Without oral phenylephrine, patients may have to resort to liquid and spray versions of the drug or explore entirely new medications, which were not considered in the FDA advisors’ review.

This two-day advisory panel meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing their failure to outperform placebo pills in patients with cold and allergy congestion.

The same researchers also questioned the drug’s efficacy in 2007, but the FDA allowed the products to remain on the market pending further research.

However, FDA staff, in briefing documents released ahead of this week’s meeting, concluded that oral formulations of phenylephrine do not work at standard or higher doses. The agency’s staff stated that only a very small amount of the drug actually reaches the nose to relieve congestion.