Posted on 11/07/24
| News Source: FDA
Washington, D.C. - Nov. 7, 2024 - The U.S. Food and Drug Administration (FDA) has proposed removing oral phenylephrine as an approved active ingredient in over-the-counter (OTC) medications for temporary relief of nasal congestion. Following a comprehensive review, the FDA determined that oral phenylephrine, which is commonly found in products like Sudafed PE and Benadryl Allergy Plus Congestion, is not effective for this use. Despite this proposal, these products remain on the market for now, as this is not a final decision.
Oral phenylephrine has been widely used in many OTC products for nasal decongestion. Some medications contain phenylephrine as a sole ingredient, while others, like Benadryl Allergy Plus Congestion, include it alongside other active ingredients, such as acetaminophen. The FDA emphasizes that the presence of phenylephrine does not interfere with the effectiveness of other ingredients in these combination products.
The FDA’s review of oral phenylephrine included examining older studies, newer data, and input from the Nonprescription Drug Advisory Committee, which unanimously agreed that scientific data do not support the effectiveness of oral phenylephrine as a nasal decongestant at its current dosage. The committee’s findings were a major factor in the FDA’s decision to propose this removal.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, reiterated the agency’s commitment to ensuring drugs are safe and effective, stating, “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.”
Consumers looking for alternatives have several options. Pseudoephedrine (found in products like regular Sudafed) remains a widely effective decongestant and is not impacted by this proposal. The FDA also advises consumers to consult healthcare providers for effective alternatives to manage congestion from colds or allergies.
The FDA is now accepting public comments on this proposed change. After considering feedback, if the FDA finalizes the decision, manufacturers would be given time to reformulate products with oral phenylephrine or to remove them from the market entirely.