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WASHINGTON — Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medicines, is ineffective in tablet form, an independent advisory committee to the U.S. Food and Drug Administration agreed Tuesday.
Phenylephrine is the main ingredient used in products like Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex.
The ingredient is considered safe to use; that was not up for debate. But many doctors have questioned phenylephrine’s effectiveness for years. These products generated nearly $1.8 billion in sales last year alone, according to data from the FDA that was presented to the Nonprescription Drugs Advisory Committee on Monday during the committee’s two-day meeting.
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.
If the FDA follows through on the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.
In that scenario, the FDA would have to work with drugstores, pharmacists and other health providers to educate consumers about the remaining options for treating congestion, panelists said.
