chevron-down Created with Sketch Beta.
December 01, 2023

FDA Deems Popular Cold Medicine Ingredient Ineffective

After a Non-prescription Drug Advisory Committee meeting, the FDA issued a statement clarifying the effectiveness of oral phenylephrine. During the meeting, the Committee reviewed data on the effectiveness of oral phenylephrine and unanimously voted that the drug is not effective for nasal decongestion at the recommended dose. The Committee cited new evidence that the current dose of oral phenylephrine is likely metabolized by the gut before it can have its intended effect and that there may have been potential bias and data issues with earlier relied-upon trials. Currently, the FDA has not issued a safety warning or any recommendations to remove oral phenylephrine from the market. However, some retailers have already pulled oral phenylephrine products from their shelves. Immediately after the FDA issued statement, CVS Health announced the removal of all products with oral phenylephrine as the only active ingredient. Phenylephrine replaced pseudoephedrine in many cold relief products in the early 2000’s when restrictions were placed on pseudoephedrine for concerns of abuse. However, many phenylephrine containing products also contain other active ingredients and therefore those products will remain on retail shelves. 

The material in all ABA publications is copyrighted and may be reprinted by permission only. Request reprint permission here.