FDA Panel Finds Common Cold Medicine Ingredient Ineffective
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FDA panel unanimously concludes that oral phenylephrine, a key ingredient in many OTC cold & allergy meds, is ineffective at relieving nasal congestion.
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Phenylephrine is found in popular OTC meds like Sudafed PE, Vicks Sinex, and Benadryl Allergy Plus Congestion.
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FDA will now decide whether to revoke phenylephrine's OTC designation, which could remove products with it from shelves.
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FDA presented evidence from multiple studies showing oral phenylephrine is no more effective than a placebo.
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Phenylephrine gained popularity as a replacement for pseudoephedrine, which was restricted due to methamphetamine abuse risk, but pseudoephedrine is more effective.