A panel of US regulatory advisers said phenylephrine, a main component of over-the-counter cold medicines including some versions of Procter & Gamble’s Nyquil, doesn’t actually work.
The committee of 16 advisers to the Food and Drug Administration voted unanimously on Tuesday that scientific evidence doesn’t prove that the nasal decongestant is effective when taken orally at recommended doses. The majority of panelists agreed that further studies to test higher doses of the drug would not be worthwhile.
The advisory committee’s decision isn’t binding, but the FDA’s own staff have also questioned phenylephrine’s efficacy. If the agency follows the panel’s recommendation, it could next begin a process to remove the drug from the market, forcing manufacturers, including P&G, Kenvue Inc. (Sudafed) and Reckitt Benckiser Group (Mucinex), to reformulate many popular cough and cold products.
The companies didn’t respond to requests for comment.
Consumers spent about $1.8 billion on products containing phenylephrine in 2022, according to the FDA, although many cold remedies with the decongestant also contain other active ingredients like antihistamines and cough suppressants.
Phenylephrine has increasingly been used as a substitute for pseudoephedrine in many non-prescription cold remedies. Commonly found in forms of Sudafed, pseudoephedrine can be used to make illegal forms of methamphetamine. Since 2006, the US government has been requiring medicines containing it to be kept behind the counter.
Pharmacist’s Dilemma
If products with phenylephrine remain on the market, pharmacists would face an ethical dilemma over whether to recommend products that don’t work, said Diane Ginsburg, a clinical professor of pharmacy practice at the University of Texas at Austin and one of the outside experts on the panel. “That just erodes trust that patients have with us,” she said at the meeting on Tuesday.
Panelists and industry representatives voiced concerns that taking the products off drugstore shelves would confuse consumers and potentially restrict people’s ability to self-treat with easily accessible over-the-counter remedies.
Others responded that remedies like nasal sprays and cold medicines kept behind the pharmacy counter are still available and effective, and that continuing to market ineffective products would present greater risks for patients.
“People really don’t like change, and this is going to change how the cold and cough aisle looks,” said panelist Susan Blalock, a behavioral scientist at the University of North Carolina’s Eshelman School of Pharmacy. “FDA really shouldn’t underestimate the communication challenges.”