FDA May End Use of Oral Phenylephrine as Nasal Decongestant Ingredient in OTC Products

A proposed order announced this week by the FDA would remove oral phenylephrine as an active ingredient included to relieve nasal congestion in over-the-counter (OTC) monograph drug products.

“Oral phenylephrine is not effective for this use,” the agency concluded after a comprehensive review of all available data on the safety and efficacy of the oral decongestant. In addition to contemporary clinical data, the review included data generated 30 years ago that were used at the time to support the claim that oral phenylephrine was an effective nasal decongestant.

Last fall, at an FDA Nonprescription Drug Advisory Committee meeting, participants discussed the ‘Generally Recognized as Safe and Effective’ status of oral phenylephrine as a nasal decongestant and unanimously concluded that “current scientific data do not support the recommended dosage” in the broad range of OTC drug products in which it is used for that purpose. The agency emphasized that its proposed order is based solely on concern for the product’s efficacy and not its safety. FDA also notes the current action does not apply to phenylephrine administered via nasal spray.

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

Oral phenylephrine is widely used as nasal decongestant in cold, cough, allergy, bronchodilator, and antiasthma OTC monograph drug products. In some it is the only active ingredient, but in others it may be combined with additional active ingredients such as acetaminophen or dextromethorphan. In combination products, phenylephrine does not affect the efficacy of other ingredients on specific symptoms, according to the FDA.

The order is currently proposed, and companies may continue to market phenylephrine-containing products until a final order is issued. FDA is currently inviting public comments on the proposal and will take the feedback into consideration when making its final decision on the use of oral phenylephrine as a decongestant in the OTC monograph. If the decision is negative, manufacturers will be provided sufficient time to either reformulate products containing phenylephrine or to withdraw them from the market, the statement said.

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

Source: FDA proposes ending use of oral phenylephrine at OCT monograph nasal decongestant active ingredient after extensive review. News release. FDA. November 7, 2024. Accessed November 8, 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after