OSP News

FDA Panel Declares Decongestant Phenylephrine Ineffective

Posted: 09/20/2023

A Food and Drug Administration-assembled board of advisers has determined that the most popular decongestant ingredient on the market is not actually effective in treating nasal congestion. The group of experts gathered by the FDA unanimously voted, declaring the ingredient phenylephrine to be no more effective than a placebo pill, according to review materials shared by the agency.

Phenylephrine can be found in most over-the-counter medications meant to target congestion, including name brands such as Sudafed and Dayquil, and became the primary ingredient following a 2006 law limiting access to the older pseudoephedrine, which can be processed to create methamphetamine.

The efficacy of phenylephrine administered orally to relieve nasal discomfort has been called into question multiple times in the past, including once in 2007. The FDA allowed the drugs to stay on store shelves at that time pending further research, but this week's findings may finally prompt the organization to demand Johnson & Johnson, Bayer and other drugmakers to pull these oral medications completely, the Associated Press reported.

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