Florida law firm files class action lawsuit against phenylephrine decongestant drugmakers
A Pensacola law firm has become the first in the country to file a nationwide class action lawsuit against Johnson & Johnson and Proctor & Gamble after a Federal Drug Administration panel unanimously voted against the effectiveness of phenylephrine, the key drug used in leading decongestant brands such as Sudafed, Allegra and Dayquil.
Advisers to the FDA held a vote last week after new studies showed that phenylephrine was no more effective as a nasal decongestant than a placebo when taken orally.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, told the Associated Press.
The law firm, Aylstock, Witkin, Kreis & Overholtz, announced the suit on Monday though the FDA has yet to make a final decision regarding whether phenylephrine-based decongestants will be removed from shelves.
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The FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine.
Phenylephrine became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters.
The Combat Methamphetamine Epidemic Act of 2005 banned over-the-counter sales of ephedrine, pseudoephedrine and phenylpropanolamine in 2006 because pseudoephedrine can be illegally processed into methamphetamine.
Some pseudoephedrine-based medicines are still available for purchase without a prescription. They can be purchased from behind the counter but have daily limits.
What happens next?
Before the FDA makes a final decision about phenylephrine, it will consider the input of its advisory committee and the evidence.
If the FDA determines that oral phenylephrine is not effective, it would first issue a proposed order removing the drug from an over-the-counter drug (OTC) monograph, which essentially defines the safety, effectiveness and labeling of OTC active ingredients.
Once the FDA issues a proposal to remove the drug, the public will have the opportunity to comment on the order. A final order from the FDA comes after it considers public input.
Afterward, phenylephrine would be removed from the monograph and the agency would work with manufacturers to reformulate products as needed.
It’s important to clarify again that the FDA panel found phenylephrine not effective in oral applications due to how quickly the drug metabolizes before reaching the nasal passages.
The panel did not review the effectiveness of the drug in nasal spray form.
What is phenylephrine and what is it used for?
Phenylephrine is a key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications that are used for temporary congestion relief caused by allergies, colds or sinus trouble.
What forms does phenylephrine come in?
Phenylephrine medications are available in oral liquid, tablets, chews, drops and nasal spray forms. Only oral variants may be impacted if the FDA follows through on the panel's recommendations.
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What are phenylephrine brand names?
Oral versions of phenylephrine medicines can be found in Sudafed PE, Vicks Sinex, Benadryl Allergy Plus Congestion, Mucinex, Nyquil and more.
Why the FDA panel says phenylephrine isn’t effective
Phenylephrine works by reducing the swelling of blood vessels in the nasal passages, but FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion.
The panel didn’t rule out phenylephrine’s effectiveness when applied directly to the nose in sprays or drops, but those products were not part of their review.
The new findings echo previous studies that show most phenylephrine products fail to outperform placebo pills in patients with cold and allergy congestion.
This article originally appeared on Pensacola News Journal: Florida law firm sues after phenylephrine found ineffective
