Feeling stuffy and ready to reach for NyQuil, Benadryl, or Sudafed PE? Not so fast. The Food and Drug Administration (FDA) has proposed ending the use of oral phenylephrine, a common ingredient found in many cold and allergy medicines — and some pharmacies already are yanking the popular products off shelves. Florida researchers have been studying the effectiveness of oral phenylephrine for two decades.
As far back as 2005, researchers at the University of Florida College of Pharmacy had suspected that this ingredient doesn’t relieve nasal congestion, even though it has been widely used for that purpose. The researchers evaluated multiple studies done on oral phenylephrine and combined them into a meta-analysis. They concluded that medications with the ingredient work no better than placebo pills in patients with cold and allergy congestion.
“For 20 years, we have been telling everyone who will listen that oral phenylephrine doesn’t work,” said Dr. Randy Hatton , a University of Florida College of Pharmacy professor. “We have been teaching pharmacy students that it doesn’t work.
We hear from pharmacists who know it doesn’t work. And we actually did something about it.” Hatton and UF professor, Dr.
Leslie Hendeles , took their findings to the FDA, more than once. Finally, in September 2023, the federal agency convened a committee and issued a proposed order. “They looked at all the evidence we looked at and did an in-depth evaluation of what we had been loo.
