Decades of research by University of Florida pharmacists Leslie Hendeles, Pharm.D., and Randy Hatton, Pharm.D., led a Food and Drug Administration advisory panel to vote unanimously on Sept. 12 that oral phenylephrine, a popular decongestant in over-the-counter cold medicines, is ineffective.
Phenylephrine has been a widely used nasal decongestant appearing in more than 260 over-the-counter products in the U.S., but its effectiveness has always been a subject of debate. Hendeles and Hatton spent years educating pharmacists, health care providers and the public that phenylephrine is ineffective when taken orally because enzymes in the gut inactivate it. The pair filed multiple citizen’s petitions, testified before advisory committees and pressured the FDA to review the safety of phenylephrine — ultimately leading the FDA’s Non-Prescription Drugs Advisory Committee to vote 16-0 in September that oral phenylephrine doesn’t work as a nasal decongestant.
Hendeles, a professor emeritus, and Hatton, a clinical professor, fielded dozens of media requests following the decision. Here are several national stories highlighting their research and reaction to the ruling.
- New York Times: Why it took so long to tackle a disputed cold remedy
- Time: With the decongestant SNAFU, the FDA tries something new
- NPR: Popular nasal decongestant doesn’t relieve congestion, FDA advisers say
- The Atlantic: How did an ineffective cold medication get so popular?
- New York Times (op-ed): We have known for 20 years this cold medicine doesn’t work
- Wall Street Journal: These are the two scientists taking down cold medicines that don’t work