Over The Counter 9 Oct 2023: What’s Going On With Oral Phenylephrine In The US? With HBW’s Malcolm Spicer
Executive Summary
In this episode, HBW Insight speaks to its own OTC expert, managing editor Malcom Spicer, about recent controversy in the US surrounding oral nasal decongestant phenylephrine.
Used widely and safely by US consumers for around a half century, the efficacy of oral phenylephrine has come under question following a 2015 citizen petition by University of Florida pharmaceutical researchers, which asked the FDA to remove the ingredient from the final OTC CCABA monograph. Only recently addressing this petition, prompted by reforms to the US OTC monograph system, an FDA advisory panel has unanimously voted that research the FDA presented during a two-day meeting in September didn’t support oral phenylephrine’s efficacy for nasal decongestion at the CCABA monograph dose of 10mg.
In this podcast, HBW Insight’s US consumer health managing editor Malcolm Spicer draws on his extensive experience and writing on this topic to take listeners beyond the headlines and offers his analysis of this crucial development, which may or may not have wider implications beyond the US.
Further Reading
Humic Acid Nasal Sprays Recalled During Potential For Sales Boost Due To Phenylephrine Doubts
Message Clear For Xylitol Nasal Spray Firm Xlear: ‘Capitalize’ On FDA’s Oral Phenylephrine Doubts
US Advisory Panel Leaves No Room For Doubt: Oral Phenylephrine Ineffective As Nasal Decongestant
US FDA Rides Different Monograph System In Second Roundup Of Oral Phenylephrine Efficacy
US FDA Finds Phenylephrine Ineffective As Nasal Decongestant, Looks At Removing From Monograph
Further Listening
Citeline podcasts are available on Apple Podcasts, Google Podcasts, SoundCloud and TuneIn - and also now on Spotify Podcasts - and via smart speakers if one of these platforms has been set up as your default podcast provider.
Over The Counter Theme Music:
Warm Vacuum Tube by Admiral Bob (c)
Copyright 2019 Licensed under a Creative Commons Attribution (3.0) license