An FDA medical advisory panel that phenylephrine (PE), a key ingredient in many over-the-counter cold medications, does not actually work to treat nasal congestion when taken orally at the recommended 10 mg dose every 4 hours. Phenylephrine was last evaluated for over-the-counter use as an oral and intranasal decongestant in 1976, according to the panel. If you’re keeping score at home, that means many of the OTC decongestants consumers in the US have been buying for nearly the last 50 years were, according to the FDA, “failed to provide any benefit over [a] placebo.”
This determination will impact drug makers that use PE as an active ingredient, which can be found in , Vicks Sinex, and Benadryl Allergy Plus Congestion, for example.
As part of the panel’s review, the FDA reported that in 2022, an estimated 242 million packages of OTC cough and allergy oral products containing PE were sold in retail stores, which raked in about $1.8 billion in sales. It even notes that the true extent of use of PE-containing cold products is likely underestimated because retail sales data does not “capture sales activity from Costco, convenience stores, specialty stores, internet sales, phone sales, or kiosks.”
The FDA will now need to determine if it will revoke PE’s oral OTC designation as “safe and effective.” Without that designation, drug makers may see their products removed from stores.