Phenylephrine (PE) is a common ingredient found in most over-the-counter (OTC) nasal congestion medications, including Mucinex Sinus Max, Sudafed PE, Tylenol Cold & Flu Severe, Benadryl Allergy Plus, Theraflu, and Nyquil Severe Cold & Flu. In 2022, nearly $1.8 billion in sales of products containing PE were made in the United States. But, on September 12, 2023, the Food and Drug Administration (FDA) found that orally administered PE medications are not effective for treating nasal congestion.
On October 5, 2023, FeganScott filed a class action lawsuit accusing Walgreens of misleading customers by marketing and selling decongestants under its brand name with a primary ingredient that the FDA deemed ineffective.
According to the lawsuit the manufacturer and retailer defendants knew that PE when taken orally was completely ineffective. For example, a 2006 report published in the Journal of Allergy and Clinical Immunology, found that PE “is unlikely to provide relief of nasal congestion” and that a study found that PE “was no more effective than placebo in reducing nasal airway resistance.” The FDA similarly noted that a 2017-2018 Johnson & Johnson trial “suggest[ed] no beneficial effect [of phenylephrine] when compared with placebo.”
On December 6, 2023, a dozen related cases were transferred to the Eastern District of New York and assigned Judge Brian M. Cogan for coordinated or consolidated pretrial proceedings.