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US FDA panel says popular decongestant used in cold medicines ineffective

WASHINGTON – An outside panel of experts to the US Food and Drug Administration (FDA) 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 Ms Jennifer Schwartzott, one of the FDA panellists.

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. REUTERS

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