Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant

This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines.

The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from their Nonprescription Drug Advisory Committee (NDAC), convened on 11 and 12 September 2023, which concluded that the current scientific data was inadequate and did not support the efficacy of orally administered Phenylephrine, at recommended dosages as a nasal decongestant. The US FDA and the NDAC did not raise any safety concerns associated with the use of orally administered phenylephrine at the recommended dose. The ACC further discussed the Pharmacovigilance Committee recommendation regarding the lack of effectiveness of orally administered nasal decongestants dated 04 March 2024.