A bottle of Vicks DayQuil cold and flu medication containing phenylephrine is displayed for sale at a CVS Pharmacy store in Hawthorne, Calif., on September 12, 2023.
Patrick T. Fallon | AFP | Getty Images
The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many common over-the-counter cold and allergy medications.
The agency said a large-scale review of available data found that the ingredient, oral phenylephrine, does not actually relieve nasal congestion. This comes more than a year after FDA advisors unanimously reached the same conclusion.
“Based on the data, we are taking this as the next step in the process of proposing removal of oral phenylephrine because it is ineffective as a nasal decongestant,” Dr. Patricia Cavazzone, director of the FDA's Center for Drug Evaluation and Research, said in a report. He releases.
The proposed order is not based on safety concerns and is not yet final, the FDA said, meaning companies can still market over-the-counter medications containing oral phenylephrine for the time being. But a final decision would force pharmacies to clear their shelves of hundreds of products that contain oral forms of the ingredient, which is found in versions of the drug such as NyQuil, Benadryl, Sudafed and Mucinex.
last year, CVS It said it has already moved to withdraw some medications containing oral phenylephrine.
The final order will also require drug makers such as Procter & GambleBayer, and Johnson & Johnson spin off Kinview To reformulate many oral cold and allergy products.
Phenylephrine is thought to relieve congestion by reducing swelling of blood vessels in the nasal passages. Without oral phenylephrine on the market, patients would likely scramble to find spray versions of the drug, or other medications with different ingredients, neither of which influenced the FDA's decision.
Retail stores such as CVS and Walgreens They could also take a hit: These stores sold 242 million bottles of medications containing phenylephrine in 2022, generating nearly $1.8 billion in sales, according to a presentation by FDA staff last year.
The FDA can specifically declassify an over-the-counter drug as “generally recognized as safe and effective.” This classification, typically used for older drugs, allows drug makers to include an ingredient in over-the-counter products without having to submit an application to the Food and Drug Administration.
The FDA advisers' meeting was convened last year by researchers at the University of Florida, who petitioned the agency to remove phenylephrine products from the market based on studies showing they failed to outperform placebo pills in patients with cold congestion and allergies.
The same researchers also questioned the drug's effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.
However, FDA staff concluded, in brief documents released before the committee meeting last year, that oral formulations of phenylephrine do not work at standard or even higher doses. A very small amount of phenylephrine actually reaches the nose to relieve congestion, the staff said.
Representatives of the Consumer Healthcare Products Association, a group that represents manufacturers of over-the-counter drugs, presented no new evidence to counter the FDA staff's conclusions about phenylephrine during a meeting last year.
But the group said withdrawing oral phenylephrine from the market would pose a significant burden on consumers.
The group shared a survey that found that one in two U.S. households used oral decongestants within the past year. It also found that people preferred oral decongestants over nasal sprays by a margin of 3 to 1.
Phenylephrine became the main decongestant in over-the-counter cold and allergy medications in 2006, when sales of another decongestant, pseudoephedrine, were restricted in the United States.
Pseudoephedrine was moved behind the pharmacy counter because it can be abused to make methamphetamine, a highly addictive stimulant drug that affects the central nervous system.
