'Dummy pill': Popular nasal decongestant fails in relieving congestion, claims FDA

Phenylephrine, the famous decongestant used for relief fromstuffy nose by millions of Americans is nothing better than a dummy pill, as per government experts.

They had reviewed the latest research on the long-questioned drug ingredient in versions of Sudafed, Allegra, Dayquil and other medications which remain stocked on store shelves.

On Tuesday, the Food and Drug Administration's advisers unanimously voted against the ingredient's effectiveness.

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” stated Dr. Mark Dykewicz, who works as an allergy specialist at the Saint Louis University School of Medicine, reported AP.

The FDA's outside advisers assembled to reassess phenylephrine, which emerged as the main drug in over-the-counter decongestants after medicines with an older ingredient, known as pseudoephedrine, went behind pharmacy counters.

Oral medications likely to be pulled down from store shelves

If the recommendations of the panel are followed by the FDA, drug makers like Bayer, Johnson & Johnson and others will need to pull their oral medications, which contain phenylephrine, from store shelves.

This is likely to force consumers to go for the behind-the-counter pills or drops and nasal sprays, which contain phenylephrine and are not under review.

The panelists on Tuesday said that in that scenario, the FDA will have to work with pharmacists, drugstores and other health providers to inform consumers about the remaining options they have for treating congestion.

The advisers also informed the FDA that understanding phenylephrine at higher doses was not an option because it increase blood pressure to dangerous levels.

“I think there’s a safety issue there,” stated Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think this is a done deal as far as I’m concerned. It doesn’t work,” he added.

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The two-day meeting, which was held this week, was organised by the researchers of the University of Florida who petitioned the FDA to remove phenylephrine products on the basis of recent studies which showed they did not outperform placebo pills in patients, suffering from cold and allergy congestion.

A patient representative on the panel Jennifer Schwartzott said, “I feel this drug in this oral dose should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.”

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