FDA proposes pulling decongestants from shelves over one ingredient

Just as cold and flu season arrives, the Food and Drug Administration proposes pulling many decongestants from store shelves.

The reason? An administration review found oral phenylephrine — a common ingredient in over-the-counter cold medications — doesn’t work. For some products, it is the only ingredient, the FDA said in a news release issued Thursday. Others contain oral phenylephrine and acetaminophen, dextromethorphan or another active ingredient.

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

To determine the ingredient’s effectiveness, the agency reviewed “all available data,” including the original, 30-year-old determination oral phenylephrine works and research since then.

The FDA also held a meeting last year to study the “Generally Recognized as Safe and Effective” status of oral phenylephrine as a nasal decongestant, the release stated. The committee “unanimously concluded that the current scientific data do 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.”

The administration pointed out these products are not a safety concern. They just don’t work. Also, this is a proposed order, so you can still buy the medication if you want. Only a final order will affect what products can be marketed.

Among the products containing oral phenylephrine as an active ingredient are Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief and Benadryl Allergy Plus Congestion and generic medications.

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