Bottles of Vicks DayQuil, a cold and flu drug containing phenylephrine, are on display and for sale at a CVS Pharmacy store in Hawthorne, California, on September 12, 2023.
Patrick T. Fallon | AFP | Getty Images
The Food and Drug Administration on Thursday proposed discontinuing the use of a common ingredient found in many common over-the-counter cold and allergy medicines.
The agency said an extensive review of available data found that the ingredient oral phenylephrine does not actually relieve nasal congestion. More than a year has passed since FDA advisers unanimously reached the same conclusion.
Based on the data, “oral phenylephrine is ineffective as a nasal decongestant, so we are moving to the next step in the process to propose the removal of phenylephrine,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. Ta. release.
The FDA said the proposed order is not based on safety concerns and is not yet final, meaning companies can continue to sell over-the-counter drugs containing oral phenylephrine for now. But if the decision is finalized, pharmacies will have to clear their shelves of hundreds of products that contain oral ingredients in drugs such as Nyquil, Benadryl, Sudafed and Mucinex.
last year, CVS It said it was already moving toward discontinuing certain medications, including oral phenylephrine.
Final orders will also require pharmaceutical companies such as: procter and gambleBayer, and johnson & johnson spin-off Kenview To reformulate many of our oral cold and allergy products.
Phenylephrine is thought to reduce nasal congestion by reducing the swelling of blood vessels in the nasal passages. If oral phenylephrine does not come to market, patients will be scrambling to find a spray version of the drug or other drugs with different ingredients, neither of which are affected by the FDA’s decision.
CVS and walgreens These stores sold 242 million drugs containing phenylephrine in 2022, generating about $1.8 billion in sales, FDA staff said last year.
Among other things, the FDA could revoke the drug’s over-the-counter designation, saying it is “generally recognized to be safe and effective.” This designation is typically used for older drugs and allows drug companies to include the ingredient in commercially available products without filing an FDA application.
Last year, an FDA advisory panel was prompted by University of Florida researchers to remove phenylephrine products from the market based on a study that showed they were not more effective than placebo pills in patients with cold and allergy congestion. petitioned the authorities.
The same researchers challenged the drug’s effectiveness in 2007, but the FDA allowed the product to remain on the market pending further research.
However, FDA staff concluded in an explanatory note posted in advance of last year’s committee meeting that oral formulations of phenylephrine are not effective at standard or higher doses. Staff say only a small amount of phenylephrine actually reaches the nose to clear nasal congestion.
Representatives from the Consumer Healthcare Products Association, a group that represents over-the-counter drug manufacturers, did not present any new evidence to refute FDA staff’s conclusions about phenylephrine at a meeting last year.
However, the group argued that withdrawing oral phenylephrine from the market would place a significant burden on consumers.
The group shared findings that one in two U.S. households used an oral nasal decongestant in the last year. They also found that people preferred oral nasal decongestants over nasal sprays by a 3-to-1 margin.
Phenylephrine became the primary decongestant in over-the-counter cold and allergy medicines in 2006, when the sale of another nasal decongestant, pseudoephedrine, was restricted in the United States.
Pseudoephedrine has been moved behind the pharmacy counter because it can be misused to make methamphetamine, a highly addictive stimulant that affects the central nervous system.
