A panel of external experts convened by the US Food and Drug Administration (FDA) on Tuesday declined to endorse the efficacy of oral over-the-counter (OTC) medications containing phenylephrine, a commonly used ingredient in cold and cough syrups.
The panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, asserting that further trials were unnecessary to establish its efficacy.
This panel decision has the potential to result in the removal of oral phenylephrine, a significant component in popular products such as Benadryl, Advil, and Tylenol, from the FDA's list of approved OTC ingredients, effectively prohibiting its sale in the United States.
It's worth noting that while the FDA typically follows the recommendations of its expert panels, it is not bound by them.
Jennifer Schwartzott, a member of the FDA panel, emphasized, "The patient community requires and deserves medications that treat their symptoms safely and effectively, and I don't believe that this medication does that."
Kenvue (KVUE.N), the manufacturer of Tylenol, and GSK (GSK.L), the marketer of Advil, did not provide immediate responses to Reuters' requests for comments.
Phenylephrine was introduced as a replacement for pseudoephedrine in many non-prescription cold and allergy medicines following restrictions on the latter due to reports of abuse.
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