The FDA is proposing to remove oral phenylephrine, widely used as a nasal decongestant in over-the-counter cold and cough medicines, after concluding it lacks effectiveness as a nasal decongestant.
RT’s Three Key Takeaways:
- FDA Proposes Action on Oral Phenylephrine: The agency’s review found oral phenylephrine, commonly used in OTC cold medicines, to be ineffective as a nasal decongestant.
- No Immediate Market Impact: For now, manufacturers can continue selling products containing oral phenylephrine, but a final FDA order would require reformulation or removal from shelves.
- Nasal Spray Form Unaffected: The proposed change targets only the oral form of phenylephrine; nasal spray products containing the ingredient are not included.
The US Food and Drug Administration is proposing to remove oral phenylephrine, widely used in cold and cough medicines, as an active ingredient that can be used OTC monograph drug products after an agency review determined it is not effective as a nasal decongestant.
Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products.
For now, companies may continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant. This is a proposed order, and only a final order will affect what products can be marketed. The proposed order is based on effectiveness concerns, not on safety concerns.
Impact on Combination Products and Consumer Guidance
The FDA says 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 (eg, 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.
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“It is the FDA’s role to ensure that drugs are safe and effective,” says Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER). “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
Review of Data and Advisory Committee Findings
The agency conducted a 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 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 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.
Advice for Consumers and Next Steps
“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” says Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, in a release. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
Because a variety of different drug products may be sold under the same brand name, the FDA notes that consumers should 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. 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.
