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FDA Panel Finds Common Decongestant Ineffective, Potentially Leading to Reformulation of Numerous Cold Medications

  • An FDA advisory panel unanimously found the oral decongestant phenylephrine ineffective in multiple studies.
  • The FDA may propose removing phenylephrine from over-the-counter medications, pending public feedback.
  • If phenylephrine is removed, major brands like Tylenol and Advil would need to reformulate their cold medicines.
  • Phenylephrine became widely used after pseudoephedrine was restricted due to methamphetamine production.
  • The FDA's historical focus on safety over efficacy likely enabled ineffective phenylephrine to remain on the market.
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