If the FDA follows through on the panel’s recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves.
That was also the recommendation of FDA's outside experts at the time, who met for a similar meeting on the drug in 2007.
“I feel this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the panel. “Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.” published ahead of this week’s meeting, which found numerous flaws with the 1960s and 1970s studies originally used to support phenylephrine’s approval.
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 . It has been sold in various forms for more than 75 years, predating the agency's own regulations on drug effectiveness.
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