On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness.
After reviewing available data, the agency determined that oral phenylephrine does not provide the expected relief for nasal congestion despite its widespread use in many OTC drug products.
This proposed order is based solely on concerns about effectiveness, not safety, and will not impact nasal spray products containing phenylephrine.
Currently, oral phenylephrine is found in various OTC products, either as a standalone ingredient or in combination with other drugs such as acetaminophen or dextromethorphan.
New York Times adds that the ingredient has been used alone and in combination with other painkillers, cough suppressants, and agents meant to ease cold and flu symptoms in medications like Kenvue Inc's (NYSE: KVUE) Tylenol, Reckitt Benckiser Plc's (OTC: RBGLY) Mucinex, and Benadryl.
However, phenylephrine in these combinations does not affect the efficacy of other active ingredients for treating cold or allergy symptoms.
Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research (CDER), emphasized that the agency's role is to ensure drugs are both safe and effective.
She noted that, after a comprehensive review of historical and recent clinical data, it became clear that oral phenylephrine does not meet the effectiveness criteria for nasal decongestion.
This conclusion is supported by the FDA's advisory committee, which last year unanimously agreed that the current scientific data does not support oral phenylephrine's use as a nasal decongestant.
In addition to the review, the FDA held a meeting of the Nonprescription Drug Advisory Committee to evaluate new evidence regarding phenylephrine's effectiveness.
Based on the committee's recommendations and additional data, the agency is moving forward with this proposed order. While the FDA has issued a proposal, it has yet to issue a final order, which would determine the future availability of products containing oral phenylephrine as a nasal decongestant.
The FDA is seeking public comments on this proposed change and will consider feedback before issuing a final decision.
If the FDA concludes that oral phenylephrine is ineffective, manufacturers must reform or remove their products from the market.