FDA Proposes Removing Oral Phenylephrine from OTC Nasal Decongestants
Key Insights
The FDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) monograph drug products for temporary nasal congestion (search) relief.
This decision follows an FDA review that concluded oral phenylephrine is ineffective in relieving nasal congestion (search) at recommended doses.
The proposal does not affect phenylephrine nasal sprays, which remain approved; the FDA will accept public comments before issuing a final order.
The U.S. Food and Drug Administration (FDA) has announced a proposal to remove oral phenylephrine from the list of active ingredients in over-the-counter (OTC) monograph drug products intended for temporary relief of nasal congestion (search). This action follows an agency review of existing data, which led to the conclusion that oral phenylephrine has not been shown to be effective as a nasal decongestant.
Ineffective Nasal Decongestant
According to Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), the FDA's role is to ensure that drugs are both safe and effective. The proposal to remove oral phenylephrine is based on a review of available data and consistent with the advice of the advisory committee.
Oral phenylephrine is a commonly used ingredient found in many OTC nasal decongestant medications, either as a single active ingredient or in combination with other drugs like acetaminophen or dextromethorphan. The FDA noted that the presence of phenylephrine in multi-ingredient formulations does not affect the function of the other active ingredients in addressing their intended symptoms.
Historical Data vs. Recent Evidence
While older research from around 30 years ago supported the use of oral phenylephrine for nasal decongestion, more recent clinical evidence suggests otherwise. The FDA’s Nonprescription Drug Advisory Committee convened to discuss the ingredient's status under the “Generally Recognized as Safe and Effective” (GRASE) designation for use in nasal decongestants. The committee unanimously agreed that current research does not support the effectiveness of oral phenylephrine at the recommended doses in OTC products.
Nasal Sprays Not Affected
The FDA clarified that this proposal does not impact phenylephrine nasal sprays, which remain approved for nasal congestion (search) treatment.
Public Comment and Next Steps
The FDA is now inviting public comments on the proposed order. Following a review of the feedback, the agency will issue its final order regarding phenylephrine’s use in the OTC monograph. If the order is finalized, manufacturers will be given time to either reformulate products containing oral phenylephrine or withdraw them from the market.
Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, stated that consumers should know that a range of safe and effective drugs and other treatments are available to temporarily relieve congestion symptoms due to allergies (search) or a common cold (search). Consumers are also encouraged to consult their doctor or pharmacist about ways to treat these symptoms.