FDA panel rules popular nasal decongestant is ineffective

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.

Drs. Hendeles and Hatton
Leslie Hendeles, Pharm.D., pictured left, and Randy Hatton, Pharm.D., appeared in this 2006 picture. The pair have researched the ineffectiveness of oral phenylephrine for decades.

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.