The U.S. FDA proposed removing oral phenylephrine as an active ingredient that can be used in OTC nasal congestion products, citing efficacy data.
The proposed order comes over a year after an FDA advisory panel unanimously agreed that phenylephrine, the country's most popular oral nasal decongestant ingredient, is ineffective. In September 2023, the Nonprescription Drugs Advisory Committee voted 16-0 against the effectiveness of oral phenylephrine as a nasal decongestant.
The agency said it conducted a comprehensive review of all available data on the safety and efficacy of oral phenylephrine, including the historical data dating 30 years back as well as newer clinical data on oral phenylephrine that have since become available.
Phenylephrine is an ingredient in many allergy and cold formulations, including Pfizer's Benadryl, Procter & Gamble's Vicks and J&J's Tylenol Sinus. Phenylephrine is also an ingredient in nasal sprays to treat congestion. The FDA’s action is only related to orally administered phenylephrine and not the nasal spray form.
The FDA is seeking public comments on the proposed order. If the agency issues a final order removing oral phenylephrine from the OTC monograph, drug products can no longer contain oral phenylephrine as a nasal decongestant and will have to be reformulated or removed from market.