After spending decades on pharmacy shelves, the leading nasal decongestant in over-the-counter cold and allergy medicines has met its downfall.
Advisers for the Food and Drug Administration this week voted unanimously, 16 to 0, that oral doses of phenylephrine—found in brand-name products like Sudafed PE, Benadryl Allergy Plus Congestion, Mucinex Sinus-Max, and Nyquil Severe Cold & Flu—are not effective at treating a stuffy nose.
The vote was years in the making. In 2007, amid doubts, FDA advisers called for more studies. With the data that has trickled in since then, the agency's own scientists conducted a careful review and came to the firm conclusion that oral phenylephrine "is not effective as a nasal decongestant [fda.gov]."