An important note is that these findings only pertain to the oral preparation of phenylephrine. The intranasal spray bypasses first-pass hepatic metabolism by virtue of the route of delivery, and ought still be considered efficacious. Pseudoephedrine does not possess the same hepatic metabolism as phenylephrine and retains demonstrable beneficial clinical effects. However, access to pseudoephedrine has been restricted since the Combat Methamphetamine Epidemic Act of 2005, the enactment of which resulted in phenylephrine’s rapid rise in consumption.

The means of widespread notification of the lack of efficacy of oral phenylephrine, primarily through lay media coverage, was likely not the intended effect of the FDA advisory report. However, the recommendations for its removal from the monograph are now widely known. Despite the barriers to access, pseudoephedrine is presently the only efficacious oral over-the-counter decongestant available, physicians should educate patients to this effect.

Dr. Radecki (@emlitofnote) i s an emergency physician and informatician with Christchurch Hospital in Christchurch, New Zealand. He is the Annals of Emergency Medicine podcast co-host and Journal Club editor.

References

1. U.S. Food and Drug Administration. NDAC briefing document: oral phenylephrine in the CCABA monograph. Efficacy of oral phenylephrine as a nasal decongestant: Nonprescription drug advisory committee meeting September 11 and 12, 2023. FDA website. Accessed November 29, 2023.
2. Meltzer EO, Ratner PH, McGraw T. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 2016;116(1):66-71.
3. Meltzer EO, Ratner PH, McGraw T. Oral phenylephrine HCl for nasal congestion in seasonal allergic rhinitis: a randomized, open-label, placebo-controlled study. J Allergy Clin Immunol Pract. 2015;3(5):702-708.