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FDA clarifies results of recent advisory committee meeting on oral phenylephrine

[9/14/2023] FDA held a Non-prescription Drug Advisory Committee meeting Sept. 11-12, 2023, to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter (OTC) cough and cold products that are indicated for the temporary relief of congestion, both as a single ingredient product and in combination with other ingredients.

The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. However, neither FDA nor the committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose.

Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision. FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine.

Many OTC medicines, including phenylephrine, are sold because they have an ingredient that FDA generally recognizes as safe and effective (GRASE) when used as recommended on the product labeling, which is documented in an “OTC monograph.” If FDA determined that oral phenylephrine is not effective, the agency would first issue a proposed order removing phenylephrine from this monograph. The public would then have the opportunity to comment on the proposed order. If, after considering the comments, FDA continued to conclude phenylephrine is not effective, the agency would issue a final order removing this ingredient from the monograph, and phenylephrine would no longer be considered GRASE. FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.

Consumers should know there is a range of products that are available for temporary relief of congestion symptoms due to allergies or a common cold. Consumers should also know that some products only contain phenylephrine. Other products contain phenylephrine and another active ingredient (e.g., acetaminophen or ibuprofen) that treats symptoms other than congestion like headaches or muscle aches, and the presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms. 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, as well as important warnings and directions for use.

Phenylephrine is also an ingredient in nasal sprays to treat congestion. The advisory committee’s discussion and recommendations only related to orally administered phenylephrine, and not the nasal spray form. Phenylephrine-containing nasal sprays will not be affected by any possible actions taken for phenylephrine in orally administered products (such as tablets or capsules that contain phenylephrine).

FDA remains committed to using all available tools to assure the safety and efficacy of FDA-regulated drug products and to help ensure that Americans have access to medicines that are safe and effective for their labeled uses.


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