Heads-Up: Oral Phenylephrine Products, Advisories and Lawsuits

Many who suffer from nasal and sinus congestion are familiar with pseudoephedrine and it’s shift from a simple purchase to one requiring a pharmacist consult and proper photo identification.

After this change, the industry pivoted to phenylephrine as a substitute for pseudoephedrine to ensure the continued availability of over-the-counter decongestants. Fast forward to now, when the FDA has recently released a briefing document on oral phenylephrine use, and whether it’s as effective as first thought.

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About the authors
Jonathon A. Fligg
Madeline Campbell, Ph.D.*

Transcript

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Tens of millions of Americans suffer from nasal and sinus congestion every year. Many have relied on an increasing number of over-the-counter nasal decongestants to relieve their symptoms where the active ingredient was pseudoephedrine. Unfortunately, instead of using the pseudoephedrine products as intended, for nasal and sinus congestion, some people began converting the products into methamphetamine.  

As a result of this misuse, Congress passed The Combat Methamphetamine Epidemic Act of 2005, which was signed into law in 2006. This legislation created new requirements for the sale of products containing pseudoephedrine. The requirement most are aware of is the need to buy pseudoephedrine from the pharmacist behind the counter and with proper photo identification. After the sale, the pharmacy is supposed to keep information about your purchase for two years in order to monitor the volumes being purchased.

In order to fill the void of over-the-counter decongestants, companies changed their product ingredients, substituting phenylephrine for pseudoephedrine in 2006. In September 2023, the Food and Drug Administration released its briefing document on oral phenylephrine use. Although phenylephrine is generally recognized as safe by the Food and Drug Administration, FDA committees have been reviewing efficacy studies of phenylephrine since 2007. The Nonprescription Drugs Advisory Committee met September 11 and 12 of 2023, and released a briefing document that concluded, quote, “we have now come to the initial conclusion that orally administered phenylephrine is not effective as a nasal decongestant at the monographed dosage of 10 mg every 4 hours as well as at doses up to 40 mg, dosed every 4 hours.” The headlines were quick to note the conclusion and speculate that the product would be pulled from shelves.

Two days later, on September 14, 2023, the FDA published on its website the current Nonprescription Drugs Advisory Committee conclusion that quote “current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant.” However, the panic may have been premature as the FDA explained there are more steps needed

“If FDA determined that oral phenylephrine is not effective, the agency would first issue a proposed order removing phenylephrine from this monograph. The public would then have the opportunity to comment on the proposed order. If, after considering the comments, the FDA continued to conclude phenylephrine is not effective, the agency would issue a final order removing this ingredient from the monograph, and phenylephrine would no longer be considered generally recognized as safe and effective. The FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.”

In 2022, sales in the United States of products that contained phenylephrine resulted in an estimated 1.8 billion dollars. The Consumer Healthcare Products Association commissioned a survey of consumers in July 2023 that found consumers relied on phenylephrine products and the removal would hurt older adults in rural communities. The Consumer Healthcare Products Association also noted that during 2023, half of United States households have purchased phenylephrine products. Since the FDA announcement, CVS indicated it would be pulling all oral phenylephrine products from its shelves. Walgreens has a question and answer page and recommends alternative products.

It has been four months since the FDA’s last comment on the status of phenylephrine. While phenylephrine may not have a future as a decongestant, there is no definitive answer yet from the FDA and no required removal of products with oral phenylephrine. Litigants, however, are not waiting. Dozens of potential class actions were filed against multiple drug manufacturers after the FDA’s September announcement. Additional class actions were filed alleging that Kenvue, the maker of Sudafed PE and Tylenol Sinus and other common medications, knew before its May 2023 initial public offering that its over-the-counter phenylephrine medications were under investigation. 

Besides costly discovery, the litigation may be further complicated if the FDA makes any additional announcements or orders the removal of oral phenylephrine products. We’ll track developments at the FDA and in this litigation and publish updates to this post as warranted.

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