The advisers also told the FDA that studying phenylephrine at higher doses was not an option because it can push blood pressure to dangerous levels. This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug. Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients. Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into use during a sweeping FDA review begun in the 1972.

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Persons: Allegra, Dayquil, ”, Mark Dykewicz, Johnson, Paul Pisaric, “, Jennifer Schwartzott, Peter Starke, drugmakers, Theresa Michele Organizations: WASHINGTON, Food and Drug Administration, Saint Louis University School of Medicine, FDA, Bayer, Archwell Health, University of Florida, Merck, Johnson, Consumer Healthcare Products Association, Congress, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: Oklahoma