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US FDA Finds Phenylephrine Ineffective As Nasal Decongestant, Looks At Removing From Monograph

Agency Asks For NDAC Input On 'Unintended Consequences' On Consumers, Industry

 
• By Malcolm Spicer

Phenylephrine doesn’t meet efficacy bar within “generally regarded as safe and effective” standard for OTC monograph drugs, agency says in briefing prepared for NDAC meeting on 11-12 September. FDA say it is “concerned about avoiding potential unintended consequences with regard to changing the GRASE status of oral PE.”

FDA asks for more input whether NDAC members say yes or no on oral phenylephrine's efficacy as a nasal decongestant. • Source: Shutterstock

The US Food and Drug Administration says potential impact on consumers and the drug industry will influence whether it decides to remove oral phenylephrine from its OTC nasal decongestant monograph after concluding that it isn’t effective in doses up to the highest studied level.

The Office of Nonprescription Drugs and other offices and divisions in the agency’s Center for Drug Evaluation and Research explain...

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