FDA to re-evaluate effectiveness of common nasal congestion ingredient

A package of Sudafed PE.
(Image credit: Tim Boyle/Getty Images)

The Food and Drug Administration (FDA) will convene a panel next week to re-evaluate the effectiveness of oral phenylephrine, a common ingredient found in numerous over-the-counter decongestants. The panel is slated meet Monday and Tuesday, just days after the FDA released a report claiming that phenylephrine likely doesn't work.

The panel will examine the potential benefits and drawbacks of phenylephrine and question medical advisers. The drug, which was first approved by the FDA in the 1970s, can be found in many varieties of anti-cold medications, including versions of Nyquil, Sudafed, Benadryl, Vicks and Mucinex.

These medications are currently classified as being "generally recognized as safe and effective," according to an FDA fact sheet. However, the FDA's recent report, released last Thursday, claimed that phenylephrine is unlikely to work in any dosages, putting that classification at high risk of being revoked.

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"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 does end up being reclassified, major drug companies like Kenvue, Procter & Gamble, Reckitt Benckiser and others would likely have to reformulate many of their flagship decongestants or pull them from store shelves, Bloomberg reported.

The effectiveness of phenylephrine has long been debated. A 2015 clinical trial of 500 adults with seasonal allergies found that phenylephrine was "not significantly better than placebo at relieving nasal congestion in adults." Dr. Wynne Armand, a primary care doctor at Massachusetts General Hospital, told NBC News she advises patients with cold symptoms "to avoid buying oral meds that have phenylephrine," and won't prescribe it.

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