By Jared S. Hopkins

U.S. health officials proposed banning an ingredient used in popular oral decongestants, a step toward removing dozens of cold medicines from store shelves.

The Food and Drug Administration on Thursday proposed removing the ingredient, known as oral phenylephrine, from its list of approved over-the-counter ingredients after determining the drug doesn't work at relieving stuffy noses.

The agency took action after The Wall Street Journal had reported that some recent studies found oral phenylephrine in certain medicines was ineffective at relieving nasal congestion. CVS Health had already said it would pull some decongestants containing phenylephrine and will no longer sell them.

After taking public comment, the FDA could issue a final decision that would end sales of medicines containing the ingredient, including certain versions of Benadryl, Mucinex and Tylenol. The agency said it would give drugmakers time to remove the products from the market or reformulate them.

Instead of taking pills that contain phenylephrine to clear congestion, people can take pills made from pseudoephedrine, antihistamines or nasal sprays, including those with phenylephrine. Physicians and pharmacists say the alternatives are effective.

"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 Theresa Michele, who leads the FDA's division that regulates over-the-counter drugs.

Kenvue, which makes Tylenol and Benadryl, and Reckitt Benckiser Group, which makes Mucinex, didn't immediately respond to a request for comment.

First permitted for use in 1938, phenylephrine wasn't subject to rigorous clinical studies that regulators require today for medications.

After the Journal's story, agency advisers concluded that phenylephrine in oral decongestants doesn't relieve nasal congestion. An FDA review found the oral phenylephrine formulations are safe but ineffective at standard or even higher doses.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

(END) Dow Jones Newswires

November 07, 2024 13:46 ET (18:46 GMT)

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