• by Tanya Gazdik , November 7, 2024

The Food and Drug Administration is seeking to pull oral phenylephrine, a widely used ingredient in cough and cold medicines, from the market.

“The agency's scientists concluded that the oral version of the drug is ineffective as a nasal decongestant,” according to CBS News. “The FDA's proposal comes more than a year after the agency's outside advisers voted against continued use of the ingredient.”

The advisors cited concerns with the initial data used to support its approval and new data questioning its effectiveness.

“A final order will force pharmacies to clear shelves of hundreds of products containing oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex,” according to CNBC. “Last year, CVS said it has already moved to pull certain medicines containing oral phenylephrine. A final order would also require drugmakers such as Procter & Gamble, Bayer, and Johnson & Johnson spinoff Kenvue to reformulate many of their oral cold and allergy products.”

Retail stores sold 242 million bottles of drugs containing phenylephrine in 2022, which generated nearly $1.8 billion in sales, according to the FDA.

“FDA said its proposal was not based on safety concerns, so companies can still market oral drugs containing the common ingredient,” according to The Hill. “The proposal is open to public comments. If the agency makes a final decision, then the drugs would have to be removed from shelves.”

Getting the medication off the shelves has been a decades-long effort for Dr. Leslie Hendeles, a pharmacy professor emeritus at the University of Florida who filed an official petition with the FDA asking them to remove the ingredient in 2007.

“He began raising concerns about the efficacy of the ingredient in the 1990s,” according to The New York Times. “It was added to cold and flu treatments as a stand-in for a more effective decongestant, pseudoephedrine, which was moved behind the counter after its use was noted in homegrown methamphetamine labs manufacturing illicit drugs.”