FDA advisers have unanimously voted against the effectiveness of phenylephrine, a key ingredient in popular over-the-counter decongestants like Sudafed and Dayquil, concluding that it offers no improvement in congestion over a placebo.

Key findings: FDA advisers have cast a unanimous vote against phenylephrine, concluding it’s ineffective.
* Dr. Mark Dykewicz, an allergy specialist at Saint Louis University School of Medicine, remarked that modern studies show no improvement in congestion with phenylephrine, a main ingredient in a wide range of over-the-counter decongestants.
* This decision could potentially lead to popular oral medications containing phenylephrine being pulled from store shelves.

The backstory: Phenylephrine became the main ingredient in decongestants after pseudoephedrine, an older ingredient, was moved behind pharmacy counters due to a law enforced in 2006.
* Pseudoephedrine, used in original versions of Sudafed and other medicines, can be illegally processed into methamphetamine, prompting the move.
* Although pseudoephedrine-based medicines remain available without a prescription, phenylephrine-based products form the majority of the $2.2 billion market for oral decongestants.

Looking forward: If the FDA follows through on the panel’s recommendations, changes may occur in the market and options for treating congestion.
* Major drug manufacturers like Johnson & Johnson and Bayer may be required to remove their phenylephrine-containing products from store shelves.
* This scenario could prompt consumers to switch to behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops, with the FDA needing to collaborate with health providers to educate consumers on treatment options.

Health concerns: The high-dose use of phenylephrine is not considered a solution as it could raise blood pressure to potentially dangerous levels.
* The FDA panel, consisting of 16 members, unanimously agreed that current evidence doesn’t show a benefit for the drug.
* Dr. Paul Pisaric of Archwell Health emphasized the safety risks of phenylephrine, opining that “it doesn’t work.”

View original article on NPR

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