The United States Food and Drug Administration (FDA) came up with a committee report on Tuesday that said Phenylephrine in its tablet form is not effective for colds and allergies. The FDA formed an independent advisory committee to test the effectiveness of the drugs.
Phenylephrine is a popular ingredient in many over-the-counter cold and allergy medicines. The ingredient is found in popular products like Benadryl Allergy Plus Congestion, Vicks Sniex, and Sudafed PE. Although the ingredient is safe for use, it was not effective against cold and allergy. For many years, several doctors questioned the effectiveness of Phenylephrine.
According to the FDA, last year alone, these products generated a sales revenue of $1.8 billion. During the two-day meeting on Monday, the Nonprescription Drugs Advisory Committee dealt with this data from the FDA.
The committee was presented with the question –
“Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant?”
The answer was a “No.” All the sixteen members of the committee unanimously voted “No,” and agreed that the issue does not need any further study.
Dr. Diane Ginsburg of the University of Texas at Austin College of Pharmacy, who was a member of the advisory committee, stated,
“We really should not have products on the market that are not effective.”
In return, the FDA assured the committee that it would take the latter’s advice seriously. However, there was no timeline.
If the agency considered reclassifying Phenylephrine from the GRASE (Generally Recognized as Safe and Effective) category, it would ask for comments from stakeholders. These stakeholders would have the opportunity to comment and provide additional data.
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