FDA Panel Votes Unanimously to Remove Ineffective Cold Medicine Ingredient Phenylephrine
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FDA advisory panel unanimously voted that the cold medicine ingredient phenylephrine is no better than a placebo for treating congestion.
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The panel cited issues with data integrity, small sample sizes, and methodological problems in older studies showing effectiveness.
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Newer studies consistent with modern clinical trial standards showed phenylephrine was not significantly different from placebo.
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The panel said phenylephrine's low bioavailability was the main reason it should be removed from the market.
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Panel members agreed the drug could work at higher doses but that would be dangerous; they unanimously voted it should be removed.