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Drug common in decongestants not effective, FDA advisers say

The Food and Drug Administration met Tuesday to re-evaluate the effectiveness of a common ingredient found in over-the-counter decongestants, according to the agency.

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The panel, which began its meeting on Monday, looked at the effectiveness of phenylephrine. The meeting happened days after the FDA released a report claiming that phenylephrine likely doesn’t work.

Panel finds decongestant ineffective

Update 3:05 p.m. EDT Sept. 12: The 16-member Nonprescription Drugs Advisory Committee unanimously found that current scientific data does not support phenylephrine’s efficacy as a nasal decongestant.

“I think the evidence (is) pretty compelling that ... this medication is not effective and really can’t be effective,” Dr. Susan Blalock, professor emeritus at the University of North Carolina at Chapel Hill’s Eshelman School of Pharmacy, said after Tuesday’s vote.

Patient representative Jennifer Schwartzott, who also voted with the committee on Tuesday, said she did not believe that more trials would change the panel’s recommendation.

“I feel that this drug and this oral dose should have been removed from the market a long time ago,” she said. “The patient community requires and deserves medications that reat their symptoms safely and effectively, and I don’t believe that this medication does that.”

— Theresa Seiger, Cox Media Group National Content Desk

Original report: Phenylephrine is used for the temporary relief of congestion or stuffiness caused by colds, sinus problems, hay fever or other allergies. Phenylephrine can be found in products such as Nyquil, Sudafed, Benadryl, Vicks and Mucinex.

While the product has been considered “generally recognized as safe and effective” since its approval in the 1970s, the FDA issued a report last week that said phenylephrine is unlikely to work in any dosages.

If the agency determines the drug is not effective, its classification would likely be revoked.

“Because this would represent a major change in the agency’s position, we believe that presenting this information in an open public forum, along with a full discussion and vote” from committee members “will be extremely helpful,” the FDA’s report said.

If phenylephrine is reclassified, drug companies would likely have to reformulate the decongestants containing the drug or pull them from store shelves, Bloomberg reported.

A clinical trial in 2015 suggested that phenylephrine was “not significantly better than placebo at relieving nasal congestion in adults.”

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