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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.
The ingredient phenylephrine is common on pharmacy shelves and has received a desigation from the FDA that it is generally recognized as safe. But losing that designation could mean big players in the OTC medicines field will pull their products from shelves or reformulate
Phenylephrine is everywhere, so much so that nearly every nasal decongestant on pharmacy shelves contains it.
Drugs that contain it generated almost $1.8 billion in sales last year, according to data presented Monday by FDA officials.
A unanimous vote by the 16-member Nonprescription Drug Advisory panel could issue a major blow to the industry.
Today's ruling only applies to oral formulations of phenylephrine.
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