Pharmacies could pull common over-the-counter cold medications including Dayquil, Sudafed and Theraflu, from store shelves after Food and Drug Administration experts determined one of their main ingredients doesn't work.
That could leave consumers scrambling to find alternatives for relief from nasal congestion, and drugmakers hurrying to devise new drug formulations to make profits.
Drugs like Sudafed, from pharmaceutical company Johnson & Johnson, are part of a roughly $2.2 billion market for oral decongestants. Products with formulations that contain phenylephrine, the drug FDA experts deemed ineffective, make up about four-fifths of that market.
"Unintended consequences"
The Consumer Healthcare Products Association, a trade group, maintains that the ingredient is in fact effective, and that the recent ruling could have significant "negative unintended consequences."
If drugs like Sudafed are temporarily pulled from store shelves, it could burden consumers by making it more cumbersome for them to treat mild illnesses.
The removal of some popular over-the-counter medications would force some consumers "to find time to seek help from a pharmacist, doctor, or clinic for an oral decongestant for a minor ailment they could otherwise self-treat," the group said in a statement before the determination was made. "Additionally, some consumers indicate they might delay or forgo treatment, which could lead to worsened clinical outcomes such as progression to acute sinusitis and increased demand for doctor and clinic visits over time."
Which drugs contain phenylephrine?
Phenylephrine is found in these and other OTC remedies for stuffy noses:
Mucinex Sinus-Max Robitussin Peak Cold Nighttime Nasal ReliefSudafed PE CongestaionTheraflu. Vicks DayQuil and NyQuil Severe Cold & Flu
Phenylephrine is also found in other types of products, such as hemorrhoid creams, but was only deemed useless as an ingredient in oral form.
How big is the market for these drugs?
All told, the drugs accounted for roughly $1.8 billion in sales for the year.
Drugmakers also market a separate class of nasal decongestants containing pseudoephedrine (PSE), instead of phenylephrine (PE). In 2006, OTC medications containing PSE were moved behind the pharmacy counter, which is when formulations with PE became more popular.
In 2022, stores sold approximately 242 million bottles or packages of OTC cold and allergy oral medications containing phenylephrine, according to an FDA report. By comparison, stores that same year sold an estimated 51 million units of PSE, representing approximately $542 million in sales in 2022, according to the FDA report.
"Sales of products containing PE, which amounted to only a small percentage of the market prior to 2006, have risen and displaced products containing PSE as an OTC decongestant, although sales of PSE, while smaller, remain," the FDA concluded.
The federal agency also acknowledged the potential "negative" impact that pulling oral PE products from shelves could have on consumers.
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September 13, 2023 at 04:39AM
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