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U.S. FDA advisers have concluded that the nasal decongestant phenylephrine is completely ineffective.



A panel of outside advisers hired by the U.S. Food and Drug Administration (FDA) on Tuesday voted against the effectiveness of a drug called phenylephrine, which is commonly included in over-the-counter medications for influenza and nasal congestion.

“The most recent studies, even when performed properly, do not show that phenylephrine improves hyperemia,” Dr. Mark Dykewicz, an allergist at San Luis University School of Medicine, told Univision Network.

The FDA restricted pseudoephedrine, which was used to combat nasal congestion, to prescription sales after phenylephrine became an over-the-counter decongestant in 2006, after pseudoephedrine was illegally converted to methamphetamine. We discovered that there was a possibility and conducted new tests. .

Investigators told Univision that if the FDA followed the expert group’s recommendations, it would require manufacturers to remove oral medications containing phenylephrine from store shelves.

The FDA will need to launch an information campaign to help consumers learn about alternatives to their treatments.

Risk of high doses

The group also told the FDA that studying phenylephrine in higher doses was not an option because it could raise blood pressure to potentially dangerous levels.

“I think there are safety issues,” said Dr. Paul Pisaric of Archewell Health in Oklahoma. “As far as I know, I think this is a closed case. It doesn’t work”.

The 16 members of the FDA panel agreed that current evidence does not show the drug is effective against nasal congestion. Earlier, researchers at the University of Florida had already warned of the drug’s ineffectiveness and called for it to be stopped.

“I think this orally administered drug should have been taken off the market a long time ago,” said Jennifer Schwartzott, a patient representative on the committee. “Patients need and deserve drugs that safely and effectively treat their symptoms, but we do not believe this drug will solve that problem,” he said in a statement reported by Univision. emphasized.

“The bottom line is that none of the original studies met modern standards of research design and conduct,” said Dr. Peter Starke, the agency’s chief medical reviewer.

Additionally, three larger, more rigorous studies published since 2016 showed no difference between phenylephrine drugs and placebo in relieving congestion.

Source: Diario.Elmundo

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