Cold Medicines May Face Shortages if Popular Decongestant Is Pulled

Recent studies find oral decongestant phenylephrine ineffective, posing dilemma for FDA. Reform may be needed in the OTC drug approval process.

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That bottle of extra-strength cold medicine from the drugstore shelf does not actually relieve stuffy nose, but removing it may cause more problems than it’s worth.

Phenylephrine, the popular decongestant found in many over-the-counter (OTC) remedies, including Dayquil, was deemed ineffective by the U.S. Food and Drug Administration (FDA) last year. Yet it remains in circulation, leaving some experts concerned that a potential removal could trigger shortages of cough syrups and other drug supply chain disruptions.

Long Road Ahead to Remove Phenylephrine

Existing data don’t support the effectiveness of phenylephrine as an oral decongestant, according to a September 2023 FDA advisory committee announcement. The agency is now requesting public comments as it weighs removing phenylephrine-containing medicines from shelves.