The FDA proposes to revoke the use of phenylephrine in over-the-counter medications, citing lack of effectiveness in relieving nasal congestion.
WASHINGTON—Changes are coming to the cold and cough aisle of your local pharmacy: US officials are moving to phase out the leading decongestant found in hundreds of over-the-counter medicines, concluding that it doesn’t actually relieve nasal congestion. Phenylephrine is used in popular versions of Sudafed, Dayquil and other medications, but experts have long questioned its effectiveness.
Last month the Food and Drug Administration (FDA) formally proposed revoking its use in pills and liquid solutions, kicking off a process that’s likely to force drugmakers to remove or reformulate products. It’s a win for skeptical academics, including researchers at the University of Florida who petitioned the FDA to revisit the drug’s use in 2007 and again in 2015. For consumers it will likely mean switching to alternatives, including an older decongestant that was moved behind the pharmacy counter nearly 20 years ago. Doctors say Americans will be better off without phenylephrine, which is often combined with other medicines to treat cold, flu, fever and allergies. “People walk into the drugstore today and see 55,000 medicines on the shelf and they pick one that is definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic. “You take away that option and it will be easier for them to self-direct toward products that really will help them.”The FDA decision was expected after federal advisers last year voted unanimously that oral phenylephrine medications haven’t been shown to relieve congestion. Experts reviewed several recent, large studies indicating that phenylephrine was no better than a placebo at clearing nasal passageways. They also revisited studies from the 1960s and 1970s that supported the drug’s initial use, finding numerous flaws and questionable data. The panel’s opinion only applied to phenylephrine in oral medications, which account for roughly $1.8 billion in annual US sale
PHENYLEPHRINE DECONGESTANT FDA OVER-THE-COUNTER MEDICATIONS NASAL CONGESTION
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