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 will convene just days after the FDA released a report claiming that phenylephrine likely doesn't work.
The panel, slated to be held on Monday and Tuesday, will examine and question medical advisers on the potential benefits and drawbacks of phenylephrine. 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.
If the panel votes to declare phenylephrine ineffective, it could lead to medications that contain phenylephrine being pulled from stores. 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, making it likely that this classification will be revoked by the panel.
"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, 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 or stop selling many of their flagship decongestants, Bloomberg reported.
The possible ineffectiveness 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.
