An FDA advisory committee has reviewed the effectiveness of the oral formulation of a very common nasal decongestant, phenylephrine, and found it does not work.
a U.S. Food and Drug Administration advisory committee voted unanimously that the oral formulation of a very common nasal decongestant, phenylephrine, is not effective. The decision could lead to this formulation of the drug being taken off the market.
Phenylephrine is found in some forms of over-the-counter medications like Dayquil, Mucinex and Sudafed PE.
„It’s amazing the amount of dollars being spent on something that really has no efficacy,“ William Figg, Pharm.D., from the National Cancer Institute, said during the committee meeting.
All over-the-counter medications hold a designation as „generally recognized as safe and effective“ by the FDA, but clinical trials have found that oral phenylephrine, or PE, does not improve nasal congestion any more than a placebo at the dosage marked for over-the-counter use.
„There are certain studies that compare it to a placebo that don’t show any discernible benefit,“ ABC News medical correspondent Dr. Darien Sutton told „Good Morning America.“
Experts first raised concerns about PE in 2007. Since then, more evidence has accumulated showing that the drug offers little to no relief for nasal congestion. This is believed to be because the drug is processed by the body before it reaches the nasal passages where it needs to work.
Now that the committee has ruled this formulation is ineffective in treating nasal congestion, the FDA will need to decide if it stays on the market.
