Press releases from pharmaceutical companies or industry news

FDA Proposes Removing Ineffective Decongestant from Sudafed, Benadryl, and Other Cold Medicines

Nov 8, 2024, 01:46 PM

The U.S. Food and Drug Administration (FDA) has proposed to remove oral phenylephrine, a widely used ingredient in over-the-counter cold and cough medicines, from the market after determining it is not effective as a nasal decongestant. This ingredient is found in popular medications such as Sudafed, Benadryl, and potentially Lemsip. Oral phenylephrine was added to cold and flu remedies in the 1990s when another decongestant, pseudoephedrine, was moved behind pharmacy counters due to illicit methamphetamine production concerns. The FDA's decision follows a review of available data and is consistent with the advice of an advisory committee. FDA Center for Drug Evaluation and Research Director stated, "It is 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 to propose removing oral phenylephrine because it is not effective as a nasal decongestant." The agency emphasized there are no safety concerns associated with the drugs, but studies show that phenylephrine is ineffective when taken as a pill or syrup. The proposal could lead to products containing oral phenylephrine being pulled from pharmacy shelves, affecting many consumers as the cold and flu season approaches.