FDA advisory panel says widely used decongestant considered ineffective
The FDA panel also declared that a higher dose of the ingredient would also be dangerous
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A Food and Drug Administration (FDA) advisory panel declared Tuesday an ingredient widely used in over-the-counter cold and allergy medications doesn't work.
All 16 members of the Nonprescription Drugs Advisory Committee (NDAC) unanimously agreed that oral phenylephrine, found in common versions of Sudafed, Mucinex, Vicks, Allegra and Dayquil, isn't effective in offering relief from nasal congestion.
Not only did the panel declare the drug ineffective, but it also warned that, at a higher dose, it can also cause someone's blood pressure to reach dangerous levels, according to a report from The Associated Press.
Walgreens pharmacy over-the-counter medicine, cough, cold and flu relief (Jeff Greenberg/Education Images/Universal Images Group via Getty Images / Getty Images)
"Poor efficacy really is a safety issue," Dr. Steve Clement, associate professor of Medical Education at the University of Virginia School of Medicine and a panel member, said Tuesday.
Jennifer Schwartzott, a patient representative on the panel, also noted Tuesday that patients not only require but "deserve medications that treat their symptoms safely and effectively." She doesn't "believe that this medication does that" and that it should have been removed from the market "a long time ago."
Sudafed and Tylenol sit on a shelf at a Morton Williams supermarket in New York April 15, 2008. (Jb Reed/Bloomberg via Getty Images / Getty Images)
The FDA has been evaluating data with regard to orally administered phenylephrine (PE) since the Nonprescription Drugs Advisory Committee challenged its effectiveness during a meeting in December 2007, according to the FDA's briefing document.
Numerous studies have been conducted since that time to reevaluate "the scientific support for use of oral PE as a nasal decongestant."
The committee held a two-day meeting this week after researchers petitioned the FDA to remove phenylephrine products due to the fact that several studies showed that it was no better than placebo pills in patients with cold and allergy congestion, according to The Associated Press.
Anna Borowik of Springfield looks at a package of Sudafed in CVS on Newbury Street. (Matt Stone/MediaNews Group/Boston Herald via Getty Images / Getty Images)
If the FDA finds phenylephrine ineffective, drugmakers could be forced to pull certain drugs from store shelves in the U.S. Consumers might also have to seek behind-the-counter pills, nasal sprays or drops. Those products are not under review.
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According to the National Institutes of Health, pseudoephedrine, a nasal decongestant, is sold behind the counter nationwide because it can be used to make methamphetamine.