FDA Proposes Ending Use of Popular Decongestant Found in Over-the-Counter Cold Medicines

The U.S. Food and Drug Administration (FDA) is proposing to end the use of a popular nasal decongestant ingredient used in many cold and cough syrups. The federal agency would like to cease use of oral phenylephrine as the active ingredient in over-the-counter drugs.

Per a press release, the FDA explained its reasons for wanting to cease the drug’s use in oral form. It’s typically administered for the temporary relief of nasal congestion. “After an agency review of the available data determined that oral phenylephrine is not effective for this use,” the FDA reported. “For now, companies may continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant.”

The statement continued, “This is a proposed order. Only a final order will affect what products can be marketed. The proposed order is based on effectiveness concerns, not on safety concerns.”

Oral phenylephrine is widely used as a nasal decongestant active ingredient in certain cold and flu medications. While some medicines treatments contain oral phenylephrine as a single, active ingredient, others are combined with acetaminophen or dextromethorphan.

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), stated, “It is the FDA’s role to ensure that drugs are safe and effective. 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.”

FDA Committee Determined Phenylephrine’s Effectiveness as a Nasal Decongestant

FDA is proposing to remove oral phenylephrine as an active ingredient that can be used in OTC monograph drug products for the temporary relief of nasal congestion after review of the available data determined that it is not effective for this use: https://t.co/QEgKkwK04j pic.twitter.com/azGEOPTkYp

— FDA Drug Information (@FDA_Drug_Info) November 7, 2024

The FDA 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.” This committee concluded “the current scientific data [does] 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.”

Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER, explained, “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. Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”

Phenylephrine is also an ingredient in nasal sprays to treat congestion. However, this action taken by the FDA is only related to orally administered phenylephrine.