Even though phenylephrine doesn’t work, the cold remedies that contain it offer other ingredients that do help ease symptoms, researchers noted. Photo by Adobe Stock/HealthDay News
The most popular cold medications in America include a nasal decongestant that has been found to be ineffective, posing a challenge for regulators, as per a new study.
Despite concerns over its effectiveness, cold remedies containing phenylephrine continue to be the preferred choice for consumers.
The U.S. Food and Drug Administration is contemplating the removal of phenylephrine from the market, following a unanimous vote by a key advisory panel in September 2023 concluding that the drug is not effective in clearing stuffy noses.
However, such a decision could lead to disruptions in the supply chain, leaving sick consumers without readily available over-the-counter options, researchers reported in the Journal of the American Medical Association.
Phenylephrine is often combined with other effective drugs such as analgesics, cough suppressants, and antihistamines, and sold as a multi-symptom product. Popular brands that include phenylephrine are Dayquil, Sinex, Mucinex, and Benadryl.
The only other nasal decongestant approved by the FDA, pseudoephedrine, has become highly regulated due to its potential for being used in the production of methamphetamine.
Pseudoephedrine-containing products can only be bought by visiting a pharmacy counter and presenting a driver’s license, thanks to a law enacted in 2005 to combat illicit meth production.
As a result, phenylephrine products have surpassed pseudoephedrine as the preferred choice for consumers seeking cold remedies.
Between 2012 and 2021, consumers purchased 19.8 billion units of phenylephrine products, compared to 13.2 billion units of pseudoephedrine products.
Even though phenylephrine doesn’t work, the cold remedies that contain it offer other ingredients that do help ease symptoms, researchers noted.
“Unlike pseudoephedrine, which is often formulated as a standalone product, most phenylephrine products were co-formulated with antihistamines or antitussives [cough suppressants], which are likely to provide some symptom relief for cough and cold symptoms,” the researchers led by Dr. Timothy Anderson, an assistant professor of medicine at the University of Pittsburgh wrote.
If the FDA proceeds with removing phenylephrine from the market, the “reformulation of all phenylephrine-containing products would be required, which could have implications for supply chains,” the researchers wrote.
This dilemma highlights the need for the FDA to enforce tighter regulations on over-the-counter medications, according to Anderson.
“The FDA needs to hold over-the-counter drugs to a standard of effectiveness similar to that of prescription drugs,” Anderson stated in a news release from the university. “A comparable pathway is needed for drugs that are sold over the counter as exists for post-approval monitoring of the risks and efficacy of prescription drugs.”
More information
The National Institutes of Health have more about phenylephrine.
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