The FDA recently proposed to remove oral phenylephrine hydrochloride and bitartrate from its guidelines for OTC drugs, declaring them ineffective as decongestants.
This change follows nearly 20 years of questioning the efficacy of these products, starting with a 2007 petition that initiated further scientific studies.
The agency has emphasized that numerous studies supporting the effectiveness of phenylephrine hydrochloride and bitartrate have not stood the test of time, prompting the proposed update.
Public comments on the FDA's proposal will be accepted until May 7, 2025, although potential shifts in political administration may affect the process.
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