The FDA has proposed the removal of oral phenylephrine as an approved active ingredient in over-the-counter (OTC) nasal decongestant products following a comprehensive review that determined that it is ineffective for this use.
The proposal comes after new data and input from the FDA’s Nonprescription Drug Advisory Committee concluded that oral phenylephrine does not reliably relieve nasal congestion at the recommended dosage.
Currently, oral phenylephrine is included in many OTC products as a single active ingredient or in combination with others like acetaminophen. The FDA emphasized that the concerns about ineffectiveness apply solely to oral forms of phenylephrine and not to nasal sprays containing the ingredient, which remain unaffected by this proposal. The proposal does not involve safety concerns but focuses on a lack of efficacy as a nasal decongestant.
The FDA’s review included historical data, which initially supported phenylephrine’s approval as an effective nasal decongestant, and recent studies challenging its effectiveness.
