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Maybe think twice before reaching for your favorite over-the-counter (OTC) cold or allergy medicine next time you have a stuffy nose.
An FDA advisory panel on Tuesday voted unanimously that phenylephrine, a key ingredient in many oral OTC cold and allergy medications, is ineffective at relieving nasal congestion—meaning drugmakers may be required to pull popular products from US shelves.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Mark Dykewicz, an allergy and immunology professor at the Saint Louis University School of Medicine, told the Associated Press.
Experts have raised concerns about the efficacy of phenylephrine—found in some formulations of Benadryl, Sudafed, and DayQuil—since 2007. After reviewing multiple studies, the agency found that patients who took medications containing phenylephrine did no better than those who took a placebo, the Wall Street Journal reported.
The FDA panel clarified, however, that the ingredient is still considered safe. Removing the drug from the market could help avoid “the unnecessary costs and delay in care of taking a drug that has no benefit,” the FDA briefing said.
But pulling the popular OTC medications from shelves may hurt consumers who “would instead need to find time to seek help from a pharmacist, doctor, or clinic for an oral decongestant for a minor ailment they could otherwise self-treat,” the Consumer Healthcare Products Association, a trade group that represents OTC drug manufacturers, said in a statement.
Some FDA panelists challenged this claim, saying patients could still access products behind the counter, like Sudafed Sinus Congestion, that contain the alternative decongestant pseudoephedrine.
“We do have an effective alternative in pseudoephedrine,” Maryann Amirshahi, panel member and emergency medicine professor at Georgetown University School of Medicine, told NBC News. “That bar to the product really isn’t as high as was described.”
Although the FDA typically follows the advice of independent advisory panels, the agency is not required to do so. It may take some time before it reaches a decision, the New York Times reported.
If the FDA follows through with the panel’s recommendation, it has the potential to disrupt the drug market. Oral products containing phenylephrine contributed to almost $1.8 billion in sales in 2022, according to the FDA briefing.