On Nov. 7, the U.S. Food and Drug Administration announced a proposed order to remove oral phenylephrine as an active ingredient used in OTC monograph drug products for the temporary relief of nasal congestion. An agency review of the available data determined that oral phenylephrine is not effective for this use. Comments are now being sought from the public. The FDA hosted a stakeholder’s call on November 8 in which ACAAI President, James Tracy, DO, participated. “Anytime a discussion is held that may affect our patients or the medicines they use, we want to be present to ensure that their interests are represented,” he said.
For now, companies may continue to market OTC products containing oral phenylephrine as a nasal decongestant. Only a final order will affect which products may be marketed. The proposed order is based on effectiveness concerns, not on safety concerns.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), in the FDA’s press release. “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.”
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. 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 anti-asthmatic drug products for orally administered phenylephrine is effective as a nasal decongestant.
“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,” said Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, in the FDA’s press release. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”
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 for the next six months. Instructions on how to submit comments are found in the proposed order available on OTCMonographs@FDA. If, after considering the comments, the FDA concludes oral phenylephrine is not effective as a nasal decongestant, the agency will issue a final order removing oral phenylephrine from the OTC monograph, and OTC drug products thereafter will no longer contain oral phenylephrine marketed as a nasal decongestant. The FDA would provide manufacturers with appropriate time to either reformulate products containing oral phenylephrine or remove such products from the market. Companies will be allowed to market these products (during the 180 days) until final orders are enacted.
Dr. Michele also stressed the importance of counseling patients to carefully read all labels to determine the active ingredients and proper dosages of the medications they are taking, noting that many combination products have similar or identical names, but different active ingredients. Specific concerns have arisen, especially with respect to acetaminophen. Doses of acetaminophen above those recommended can lead to major health risk and death.
A page for consumers about phenylephrine also is available on the FDA website.
The Advocacy Council – ADVOCATING FOR ALLERGISTS AND THEIR PATIENTS.
Related Information
- Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine
- Federal Register: Public Inspection: Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter Human Use
- FDA clarifies results of recent advisory committee meeting on oral phenylephrine
- September 11-12, 2023: Meeting of the Nonprescription Drugs Advisory Committee
- OTC Drug Review Process
- Annual Forecast for Planned Monograph Activities
- Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter Human Use
- OTC Monographs Frequently Asked Questions
