US FDA panel says popular decongestant used in cold medicines ineffective

[September 13, 2023]  (Reuters) - An outside panel of experts to the U.S. Food and Drug Administration on Tuesday refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, an ingredient widely used in cold and cough syrups.

The panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.

The panel vote could lead to the removal of oral phenylephrine, which is a major component of popular products like Benadryl, Advil and Tylenol, from the FDA's list of approved OTC ingredients, barring its sale in the United States.

The FDA usually follows the recommendations of its expert panel but is not obligated to do so.

"The patient community requires and deserves medications that treat their symptoms safely and effectively and I don't believe that this medication does that," said Jennifer Schwartzott, one of the FDA panelists.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Kenvue, the maker of Tylenol, and GSK, which markets Advil, did not immediately respond to Reuters requests for comment.

Phenylephrine was substituted for pseudoephedrine in many non-prescription cold and allergy medicines after the latter was restricted amid reports of abuse.

(Reporting by Mariam Sunny in Bengaluru; Editing by Devika Syamnath)

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