Pharmacies could pull common over-the-counter 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 can leave consumers scrambling to find alternatives for nasal congestion relief, and drug manufacturers scrambling to devise new drug formulations to make money.
Drugs like Sudafed, from pharmaceutical company Johnson & Johnson, are part of a roughly $2.2 billion market for oral decongestants. Products with formulations containing 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 indeed 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 difficult for them to treat mild illnesses.
The removal of some popular over-the-counter medications would force some consumers “to find the time to seek help from a pharmacist, a doctor or a clinic for an oral decongestant for a minor ailment they could otherwise treat themselves,” the group said in a announcement before the decision was made. “Additionally, some consumers report that they may delay or forgo treatment, which may lead to worsened clinical outcomes, such as progression to acute sinusitis and increased demand for physician and clinic visits over time.”
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Which medicines contain phenylephrine?
Phenylephrine is found in these and other OTC nasal decongestants:
- Mucinex Sinus-Max
- Robitussin Peak Cold Nighttime Nasal Relief
- Sudafed PE Congestion
- Theraflu.
- Vicks DayQuil and NyQuil Severe Cold and Flu
Phenylephrine is also found in other types of products, such as hemorrhoid creams, but was only considered useless as an ingredient in oral form.
How big is the market for these drugs?
All told, the drugs accounted for about $1.8 billion in sales for the year.
Drug manufacturers also market a separate class of nasal decongestants containing pseudoephedrine (PSE) instead of phenylephrine (PE). In 2006, over-the-counter medications containing PSE were moved behind the pharmacy counter, where 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 a FDA report. By comparison, stores sold an estimated 51 million units of PSE that same year, which equates to approximately $542 million in sales by 2022, according to the FDA report.
“Sales of products containing PE, which represented only a small percentage of the market before 2006, have increased and displaced products containing PSE as an OTC decongestant, although sales of PSE are still smaller,” the FDA concluded.
The federal agency also acknowledged the potential “adverse” impact that pulling oral PE products off the shelves could have on consumers.