The key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications.
Advisers to the Food and Drug Administration voted unanimously Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra, 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.
This week’s two-day meeting was prompted by University of Florida researchers who petitioned the FDA to remove most phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also, but the FDA allowed the products to remain on the market pending additional research.
“The bottom line is that none of the original studies stand up to modern standards of study design or conduct,” said Dr. Peter Starke, the agency’s lead medical reviewer.
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