Phenylephrine Oral Decongestants Class Action Lawsuits & Settlements
Class Action lawsuits filed against makers of some over-the-counter oral decongestants stem from a Federal Drug Administration (FDA) study that concluded these phenylephrine-based congestion medications are not effective.
We are no longer accepting these cases.
What We Know About the Nasal Decongestants Lawsuits
In 2018, new FDA guidance for evaluating nasal congestion-related symptoms revealed that previous data about the effectiveness of phenylephrine, a common decongestant ingredient in over-the-counter cold medicines, was unreliable.
On September 12, 2023, an FDA Advisory Panel came to the unanimous conclusion that phenylephrine is ineffective.
A lawsuit filed against Johnson & Johnson’s consumer business (now known as Kenvue) and Procter & Gamble alleges that by 2018, the decongestant makers should have recognized the “false and deceptive” nature of their marketing claims regarding phenylephrine products.
According to this Complaint, the plaintiff purchased Johnson & Johnson's Sudafed PE and Benadryl Allergy Plus, and Procter & Gamble's Vicks NyQuil, because these companies claimed they worked.
Lawsuits with similar claims have been filed against the makers of TheraFlu (GSK) and Mucinex Sinus Max (Reckitt Benckiser). Walgreens makes generic oral decongestants and has also been named in such lawsuits.
Makers Knew or Should Have Known the Decongestants Didn’t Work
Given the number of scientific studies indicating the ineffectiveness of oral OTC phenylephrine-based cold medicines, combined with the FDA’s concerns in 2018, the makers of these medicines knew or should have known what they were selling to consumers was not effective.
Instead, these pharmaceutical giants continued to market and sell these worthless drugs to people who counted on them. The dollars were just too hard to resist.
Around 242 million products with phenylephrine were sold in the United States in 2022, according to the FDA. The makers of these products generated $1.76 billion in sales from these drugs, which constitutes around 80% of the oral decongestants market.
Examples of Phenylephrine Decongestant Brands
Several over-the-counter oral decongestants contain phenylephrine.
Examples of these medications include:
- Sudafed PE
- Sinex Nighttime Sinus Relief
- Vicks Nyquil
- Benadryl Allergy Plus Congestion
- Mucinex Sinus-Max Severe Congestion Relief Tablets
- Tylenol Cold + Flu Severe Medicine
- Walgreens Sinus Relief Congestion Day Caplets
The Consumer Healthcare Products Association told NBC News that users prefer tablets to nasal sprays three to one and that 50% of U.S. households used an oral decongestant in the last 12 months.
What Is the Purpose of Phenylephrine in Decongestant Medicines?
Phenylephrine is a key ingredient used in over-the-counter medications designed to provide relief of temporary congestion resulting from colds, allergies, or other forms of sinus trouble. The drugs are available in oral (tablet or liquid) or nasal spray forms.
By temporarily reducing the size of swollen blood vessels in nasal passages, phenylephrine can relieve stuffy nose symptoms of nasal congestion. However, the FDA reports that when taken orally, very little phenylephrine reaches the nose, making these oral medications no more effective than a placebo.
Phenylephrine surfaced as the key ingredient in OTC decongestants after the Combat Methamphetamine Epidemic Act of 2005 pushed pseudoephedrine-based decongestant medications behind pharmacy counters. OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine were banned in 2006 because they could be used to make illegal methamphetamine.