US FDA Rules Against Common Decongestant as Louisiana Allergy Sufferers Ponder Future of Benadryl and Sudafed
(KPEL News) - Could your go-to allergy and cold medicine be pulled from your pharmacy's shelves? A US Food and Drug Advisory panel's determination on Tuesday could make that a reality as thousands of people in Louisiana have struggled with sinus issues themselves over the last few weeks.
In a unanimous vote, the panel concluded that phenylephrine, a common over-the-counter decongestant found in Benadryl, Sudafed PE, and Vicks Nyquil Sinex Nighttime Sinus Relief, simply doesn't work and is no better than taking a placebo. In this NBC News article, one of the advisory committee members from North Carolina said she's seen "pretty compelling that this medication is not effective. I don’t think additional data are needed to support that conclusion."
Many of the people who spent $1.8 billion in 2022 on these medicines would disagree as they use these medicines to fight nasal congestion. This ruling, however, could lead to these over-the-counter drugs being pulled off the counter, leaving allergy sufferers to go with the less-preferred nasal spray options.
The side effects from phenylephrine may not surprise users, though.
- Increased Blood Pressure
As The Hill points out, the FDA has been looking at phenylephrine since at least 2007, back when the findings against the drug weren't as conclusive as the FDA advisory panel says they are now.
What the Next Step for the US FDA?
Will the FDA revoke phenylephrine's OTC designation as “generally recognized as safe and effective?” History shows the FDA siding with its advisory committees.
As this New York Times article points out, there is no timetable set on when the FDA would pull the medication. And, don't be surprised to see the U.S. Congress or even the White House get involved before an FDA final ruling is given out.