FDA Proposes Removing Oral Phenylephrine as an Approved Nasal Decongestant

The U.S. FDA has proposed removing oral phenylephrine from OTC medications as an approved nasal decongestant, citing concerns about its effectiveness. This decision follows an FDA review and aligns with recommendations from an advisory committee. For now, companies can continue selling products containing oral phenylephrine, which is often combined with other active ingredients like acetaminophen. The FDA emphasizes that this proposal is due to effectiveness, not safety issues. A final order is required to determine the impact on marketed products.¹

Read more here.

References

1. Office of the Commissioner. (2024, November 7). FDA proposes ending use of oral phenylephrine as OTC monograph nasal decongestant active ingredient after extensive review. U.S. Food And Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after

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