A medicine used by millions of Americans for a stuffy nose does not work, a Food and Drug Administration panel ruled today.
Phenylephrine is the most common active compound in over-the-counter drugs like Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night.
But an FDA panel said after a two-day review that the oral decongestant ‘is not effective’ at standard or even high doses compared to a placebo.
Their ruling is not binding but strongly suggests the agency could soon heed their advice and pull its approval, forcing companies to pull or reformulate their products.
The ingredient is protected under the FDA’s Generally Recognized as Safe and Effective (GRASE) designation, but a reversal of its approval could mean manufacturers including Bayer and Johnson and Johnson might need to reformulate.