A tough nut to crack

FDA declares popular decongestant ineffective - so what does work?

Hundreds of cold medicines face phaseout as officials confirm the drug fails to ease nasal congestion.

(Photo: fizkes/ Shutterstock)

Changes are coming to your pharmacy's cold and cough aisle: U.S. officials are preparing to phase out the top decongestant found in hundreds of over-the-counter medicines after concluding it doesn’t actually relieve nasal congestion.

Phenylephrine, a key ingredient in popular products like Sudafed and DayQuil, has been under scrutiny for years. Last month, the FDA formally proposed revoking its approval for use in pills and liquid solutions, paving the way for drugmakers to reformulate or remove these products.

This decision marks a victory for researchers, including those at the University of Florida, who first challenged the drug’s effectiveness in 2007. For consumers, it means turning to better alternatives, including pseudoephedrine, an older but proven decongestant moved behind the pharmacy counter two decades ago.

“Taking away ineffective options will guide people toward products that actually work,” said Dr. Brian Schroer of the Cleveland Clinic.

The FDA's action follows last year’s unanimous recommendation by federal advisers that oral phenylephrine has not been shown to relieve congestion. Modern studies found it no better than a placebo, while older research supporting its approval was deemed flawed.

What are the alternatives?

Consumers can find pseudoephedrine-based products, like Sudafed and Claritin D, at the pharmacy counter with a photo ID.

For those seeking immediate, over-the-counter options, doctors recommend saline rinses for quick mucus relief or nasal steroids, such as Flonase and Nasacort, for long-term effectiveness. Antihistamine sprays like Astepro can also provide faster, short-term relief.

Phenylephrine-based nasal sprays will remain available, but experts stress that consumers should focus on proven remedies for genuine congestion relief.

* The Associated Press contributed to this article.


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