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.