Government experts have determined that the leading decongestant used by millions of Americans may be no more effective than a placebo. The Food and Drug Administration’s advisers recently voted unanimously against the effectiveness of phenylephrine, the ingredient found in popular over-the-counter medications like Sudafed, Allegra, and Dayquil. “Modern studies are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.
Phenylephrine became the main ingredient in over-the-counter decongestants after pseudoephedrine, the previous ingredient, was moved behind pharmacy counters due to concerns about its potential for illegal production of methamphetamine. However, if the FDA follows the panel’s recommendations, oral medications containing phenylephrine may be pulled from store shelves. This would require consumers to switch to behind-the-counter pills or nasal sprays and drops containing phenylephrine. The FDA would need to work with drugstores and health providers to educate consumers about alternative options for treating congestion.
The decision could have significant implications for drugmakers like Johnson & Johnson and Bayer, as well as for the $2.2 billion market for oral decongestants. It remains to be seen when the FDA will make its next move.
(Read more FDA stories.)
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