The US Food and Drug Administration (FDA) has proposed removing oral phenylephrine as an active ingredient from over the counter (OTC) nasal decongestants.
After reviewing available data, the FDA concluded that oral phenylephrine is not effective for relieving nasal congestion. For now, companies can still sell OTC products with this ingredient, said the US regulator.
The proposal is based on effectiveness, not safety. FDA said a final decision will determine which products can remain on the market.
Oral phenylephrine is currently used in OTC monograph drug products, including cold and cough syrups, for the temporary relief of nasal congestion. It is being used in products such as Benadryl, Advil, and Tylenol.
Some medicines contain only oral phenylephrine, while others combine it with additional ingredients like acetaminophen or dextromethorphan.
FDA Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni said: “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.”
The FDA conducted a thorough review of all data on oral phenylephrine’s safety and efficacy. This included both historical data, which supported its effectiveness as a nasal decongestant 30 years ago, and newer clinical studies on oral phenylephrine that have since become available.
Last fall, the FDA’s Nonprescription Drug Advisory Committee reviewed oral phenylephrine’s GRASE status.
After discussing the new data, the committee unanimously concluded that current scientific evidence does not support the effectiveness of oral phenylephrine as a nasal decongestant at the recommended OTC dosage in the OTC cold, cough, allergy, bronchodilator and antiasthmatic drug products monograph.
The health agency said consumers should always read the Drug Facts label to check ingredients, warnings, and usage directions. The FDA’s action only affects orally administered phenylephrine, not the nasal spray form.
The FDA is requesting public comments on the proposed order.
Furthermore, if the American health regulator concludes oral phenylephrine is ineffective as a nasal decongestant, a final order will remove it from the OTC monograph. Manufacturers will be given time to reformulate or remove affected products from the market.
The Consumer Healthcare Products Association expressed disappointment over the FDA’s proposal and plans to review and comment.
