independent.co.uk
FDA Proposes Removing Phenylephrine from Decongestants
The FDA proposes removing oral phenylephrine from over-the-counter nasal decongestants due to ineffectiveness, sparking debate among healthcare organizations.
English
United Kingdom
Us PoliticsHealthLifestyleHealthcareRegulationFdaMedicineDrug
Food And Drug Administration (Fda)Consumer Healthcare Products Association (Chpa)Proctor & GambleKenvue
Patrizia CavazzoniScott Melville
- Is the FDA's proposal based on safety concerns?
- The FDA's proposal is not based on safety concerns; oral phenylephrine's presence doesn't affect how other active ingredients work. The proposed removal only applies to orally administered phenylephrine, not nasal sprays.
- What is the current status of products containing oral phenylephrine?
- While the FDA's proposal is not yet a final order, companies can still market products containing oral phenylephrine as a nasal decongestant for now. A final order will determine which products can be marketed.
- Why is the FDA proposing to remove oral phenylephrine from nasal decongestants?
- The FDA proposes removing oral phenylephrine from over-the-counter nasal decongestants because data shows it's ineffective as a nasal decongestant. This action is based on a review of available data and an advisory committee's advice, and it doesn't affect the nasal spray form of phenylephrine.
- What led to phenylephrine becoming the main ingredient in over-the-counter decongestants?
- Phenylephrine replaced pseudoephedrine as the main ingredient in over-the-counter decongestants after pseudoephedrine-containing medicines were moved behind pharmacy counters due to potential misuse. This shift happened years ago.
- How has the Consumer Healthcare Products Association (CHPA) responded to the FDA's proposal?
- The Consumer Healthcare Products Association (CHPA) opposes the FDA's proposal, arguing that oral phenylephrine is the only readily available oral decongestant without restrictions. They believe consumers should have access to a wider choice of over-the-counter medications.