A key ingredient in many over-the-counter cold and allergy medications called phenylephrine was declared ineffective by the Food and Drug Administration (FDA).
On Tuesday, the FDA announced that the ingredient widely used in your ‘go-to’ medications, does not work, raising the question for dozens of products to be removed from U.S. store shelves. Notorious medicines like Tylenol Mucinex and Benadryl, as well as over-the-counter syrups and liquids like NyQuil and Sudafed all contain phenylephrine, expected to clear up nose congestion.
Your favorite medicine for a stuffy nose may soon be unavailable after an FDA advisory panel declared a primary ingredient ineffective https://t.co/61O61ZAwmM
— The Wall Street Journal (@WSJ) September 12, 2023
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According to the New York Times, the FDA will be making its own decision on whether to remove medications containing phenylephrine. “It’s not a safety issue. It’s an effectiveness issue,” said Dr. Mark Dykewicz, an allergist and immunologist at Saint Louis University School of Medicine.
As seasons begin to change, consumers would want to look for alternative medications that work.
“Me, personally, I wouldn’t want myself or my kid to take anything that’s unnecessary and that’s demonstrated ineffective,” said Jennifer Le, a member of the advisory committee and a professor of clinical pharmacy with the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego.
“This drug and this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, a patient representative from New York. “The patient community requires and deserves medications that treat their symptoms safely and effectively and I don’t believe that this medication does.”
Pseudoephedrine, an ingredient found in certain behind-the-counter medicines like Afrin, has been proven effective at clearing congestion, according to Dr. Dykewicz. However, it is not recommended that one takes these medications past five days.
The FDA has yet to issue a final decision and could take some time before the agency announces whether they will be pulling certain medications from store shelves.
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