The Food and Drug Administration (FDA) will convene a committee next week to reevaluate the effectiveness of oral phenylephrine, a common ingredient in many over-the-counter nasal decongestants.The committee is expected to convene a few days after the FDA releases its report. report They claim that phenylephrine probably doesn’t work.
of panelScheduled to meet on Monday and Tuesday, we will survey and ask medical advisors about the potential benefits and drawbacks of phenylephrine. The drug was first approved by the FDA in the 1970s and is included in a variety of anti-cold medications, including versions of NyQuil, Sudafed, Benadryl, Vicks, and Mucinex.
If the committee votes to declare phenylephrine invalid, medicines containing phenylephrine could be removed from store shelves. The FDA says these drugs are now classified as “generally recognized as safe and effective.” fact sheet. However, a recent FDA report released last Thursday argues that phenylephrine is unlikely to be effective at any dose, making it likely that this classification will be reversed by the committee. .
“Because this represents a significant change in the agency’s position, we believe it is important to present this information in the public domain, with full discussion and voting by committee members,” the FDA report said. ”.
If phenylephrine is ultimately reclassified, major pharmaceutical company Companies like Kenvue, P&G, and Reckitt Benckiser will have to reformulate or discontinue many of their leading nasal decongestants. bloomberg report.
The possible ineffectiveness of phenylephrine has long been debated.a 2015 clinical trials Among 500 adults with seasonal allergies, they found that phenylephrine was “not significantly superior to placebo in reducing nasal congestion in adults.” Dr. Win Armand, a primary care physician at Massachusetts General Hospital, said: NBC News She advises patients with cold symptoms to “avoid purchasing oral medications containing phenylephrine” and will not prescribe phenylephrine.
