After an agency analysis of the available evidence found that oral phenylephrine is ineffective for this use, The U.S. Food and Drug Administration announced is proposing to remove it as an active component that can be used in over-the-counter (OTC) monograph drug products for the brief alleviation of nasal congestion. OTC monograph medication items that contain oral phenylephrine as a nasal decongestant may still be marketed by corporations for the time being. This order is being proposed. The products that can be promoted will only be impacted by a final order. Concerns about efficacy, not safety, are the foundation of the proposed order.
Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products. It is important to note that some products only contain oral phenylephrine as a single, active ingredient. Others contain oral phenylephrine and another active ingredient (e.g., acetaminophen or dextromethorphan), and the presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended.
The agency conducted a comprehensive review of all available data on the safety and efficacy of oral phenylephrine, including the historical data that were used to support the determination made 30 years ago that oral phenylephrine was effective as a nasal decongestant, as well as newer clinical data on oral phenylephrine that have since become available. Last fall, the FDA also held a Nonprescription Drug Advisory Committee meeting to discuss the ‘Generally Recognized as Safe and Effective’ (GRASE) status of oral phenylephrine as a nasal decongestant. The committee discussed new data on the effectiveness of orally administered phenylephrine and unanimously concluded that the current scientific data do not support that the recommended dosage in the OTC cold, cough, allergy, bronchodilator and antiasthmatic drug products monograph for orally administered phenylephrine’s effectiveness as a nasal decongestant. Because a variety of different drug products may be sold under the same brand name, consumers should always read the Drug Facts label to determine which ingredients are in a medication, and to be aware of important warnings and directions for use. 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 this proposed order. Instructions on how to submit comments are found in the proposed order available on OTC Monographs@FDA. If, after considering the comments, the FDA concludes oral phenylephrine is not effective as a nasal decongestant, the FDA will issue a final order removing oral phenylephrine from the OTC monograph, and drug products thereafter could no longer contain oral phenylephrine as a nasal decongestant. The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market.
