Study Warns of Supply Chain Disruptions if Ineffective Nasal Decongestant Recalled

Nearly 20 billion units of phenylephrine were sold between 2012 and 2021, but last year FDA advisors determined the nasal decongestant is ineffective and the agency is considering recalls for Sudafed, Tylenol and other drugs

In response to recent evidence showing the oral nasal decongestant phenylephrine is ineffective, there have been growing calls to recall Sudafed, Tylenol and other popular over-the-counter cold and flu medications that contain the ingredient. However, a new study suggests that recalling phenylephrine could create massive disruptions in the cold medication supply in the U.S.

Phenylephrine and pseudoephedrine are the only two oral nasal decongestants currently available in the U.S. and phenylephrine is still widely found in a number of popular products, including NyQuil, Mucinex, Theraflu and Benadryl.

In September 2023, the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee (NDAC) unanimously determined phenylephrine is ineffective when taken orally through pills, tablets or liquids.

Following the FDA determination, the group Public Citizen called for the agency to remove phenylephrine from the market on September 15, 2023. The FDA is not required to follow the recommendations made by its advisory committees, but the agency usually does, and is currently in the process of deciding whether to ban the drug. If the FDA decides to ban phenylephrine, it could lead to recalls impacting hundreds of cold, flu, and allergy drugs.

In the meantime, class action lawsuits over economic loss have begun to be filed against a number of drug manufacturers, including Bayer, Johnson & Johnson, GlaxoSmithKline, Pfizer and others, as well as major retailers such as CVS and Amazon.

In a new study published this month in the Journal of the American Medical Association (JAMA), researchers from the University of Pittsburgh in Pennsylvania and the University of Toronto in Ontario, Canada indicate phenylephrine was the most commonly purchased oral decongestant in the U.S. between 2012 and 2021.

Nearly 19.8 billion units of phenylephrine products were sold during that time, compared to 13.2 billion units of pseudoephedrine products, which could create potential supply chain disruptions if the products are recalled, according to the findings.

Phenylephrine Ban May Impact Supply Chain Distributions

In the report, a team of researchers analyzed quarterly phenylephrine and pseudoephedrine sales data in the U.S. from 2012 through 2021, finding pharmacies purchased more phenylephrine products than pseudoephedrine during each year among the study period. The data also revealed pseudoephedrine sales declined significantly from 1.68 billion products in 2012, to 0.98 units in 2021, while phenylephrine sales remained steady.

The study indicates that pseudoephedrine is normally sold as a stand-alone product, but phenylephrine is commonly combined with other drugs, such as acetaminophen or antihistamines, and marketed as a multi-symptom relieving medications.

Researchers warn that if the FDA decides to follow its advisory panel’s recommendations and ban phenylephrine, most multi-symptom products will be removed from U.S. shelves. This could potentially disrupt supply chain distributions of cold and flu products, as there is a lack of alternative oral decongestant drugs. A ban and subsequent recall of phenylephrine products will leave pharmaceutical companies with the decision to either reformulate their products or remove them entirely, researchers warn.

The reformulation and introduction of new products will take an unspecified amount of time, researchers indicate. They suggest clinicians and consumers consider using oral pseudoephedrine or nasal sprays that include phenylephrine or oxymetazoline as alternative options.

The researchers also call for the FDA to implement the same post-approval review process it requires for prescription drugs to over-the-counter medications, to more effectively observe how safe and effective they are.