FDA proposes removal of oral Phenylephrine from OTC nasal decongestant products

On 7 November 2024, the U.S. Food and Drug Administration (FDA) announced a proposal to remove oral phenylephrine from over-the-counter (OTC) drugs marketed as nasal decongestants. The proposal follows an agency review that concluded oral phenylephrine is ineffective in providing temporary relief of nasal congestion. Until a final order is issued, however, companies may continue to sell OTC products containing oral phenylephrine for nasal decongestion.

The proposed order arises from concerns about effectiveness rather than safety. Oral phenylephrine is currently widely used in OTC drugs as a nasal decongestant and appears both as a single active ingredient and in combination with other ingredients, such as acetaminophen or dextromethorphan. According to the FDA, the presence of phenylephrine in these combined products does not impact the effectiveness of other active ingredients in treating their respective symptoms.

“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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 FDA’s review encompassed all available safety and efficacy data on oral phenylephrine, including historical data that led to its approval for nasal decongestion over 30 years ago, as well as recent clinical data. In the autumn of 2023, the FDA’s Nonprescription Drug Advisory Committee convened to assess the status of oral phenylephrine under the ‘Generally Recognised as Safe and Effective’ (GRASE) category for nasal decongestion. The committee reviewed new data regarding the oral administration of phenylephrine and unanimously concluded that the current scientific evidence does not support its effectiveness at the recommended OTC dosage.

Theresa Michele, M.D., director of the Office of Nonprescription Drug Products at CDER, highlighted the availability of alternative treatments. “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 Dr. Michele. She advised consumers to consult healthcare professionals for further guidance.

Since many products may be sold under the same brand name, the FDA advises consumers to check the Drug Facts label on medications to confirm the active ingredients and to heed any associated warnings and directions. Phenylephrine is also found in nasal sprays, which are not affected by this proposed change, as the FDA’s action pertains solely to orally administered phenylephrine.

The FDA has opened a public comment period on the proposed order. Following consideration of these comments, if the FDA affirms its conclusion on the lack of effectiveness, a final order will be issued to remove oral phenylephrine from the OTC monograph. This would prevent its inclusion in future OTC nasal decongestant products. Manufacturers would be granted an appropriate period to either reformulate products or remove them from the market.