Phenylephrine Decongestant Lawsuit
A September 2023 U.S. Food and Drug Administration (FDA) Non-prescription Drug Advisory Committee has declared unanimously that phenylephrine may be ineffective at relieving nasal congestion when taken orally. Phenylephrine is a common ingredient in many allergy, decongestant, cough, cold and flu products sold over-the-counter.
Manufacturers of certain brands of products containing phenylephrine may be facing numerous lawsuits. People who purchased certain brands of oral over-the-counter medications containing phenylephrine may be eligible for compensation.
Common Brand Products with Phenylephrine
An FDA Advisory Panel has determined that phenylephrine may be ineffective at relieving nasal congestion when used orally. Phenylephrine is one of only two nasal decongestant medications available without a prescription but may not work as intended or advertised.
Phenylephrine is found in common over-the-counter medication brands including:
- Alka-Seltzer Plus Severe Allergy
- Alka-Seltzer Plus Cold
- Alka-Seltzer Plus Multi-Symptom
- Benadryl Allergy Plus Congestion
- Delsym Multi-Symptom
- Norel AD
- Mucinex Sinus Max
- Mucinex Fast-Max
- Mucinex Free from Cold & Flu
- Mucinex Nightshift
- Mucinex Nightshift Sinus
- Robitussin Multi-Symptom
- Sudafed PE
- Theraflu Severe Cold & Cough
- Tylenol Sinus
- Tylenol Cough and Cold
- Tylenol Cold and Flu
- Tylenol Cold Multi-Symptom
- Vicks Nyquil
- Vicks DayQuil
- Vicks QlearQuil
- Vicks Sinex
Phenylephrine is also found in generic equivalent versions of popular brand names and sold by national chain pharmacies and big-box retailers like Walgreens, CVS, and Walmart.
Phenylephrine Products May Be Ineffective
Phenylephrine is an older medication which has been in use for a number of years but may have lacked adequate comparison studies using good clinical practices to establish effectiveness. Products using phenylephrine as a decongestant ingredient relied on the FDA’s classification of the medication as “generally recognized as safe and effective” or GRAS.
Phenylephrine works to relieve nasal decongestion by constricting swollen blood vessels in nasal tissue which cause nasal congestion. The recent FDA advisory committee concluded that not enough phenylephrine reaches the nasal passages when the medication is taken orally. This may make the use of oral phenylephrine ineffective, not much better than a placebo. The FDA has clearly stated that phenylephrine would still be considered safe but may not be effective, and therefore could not be included in medications under GRAS.
The FDA will be working to determine whether the drug and products that contain it should be discontinued or reformulated. If the GRAS designation is removed from phenylephrine, combination products containing the medication may require reformulation.
Manufacturers Promoted Phenylephrine Products as Safe and Effective
In large, highly visible promotional campaigns and advertising, manufacturers marketed their phenylephrine-containing products as effective decongestants. Many people may have purchased these medications at higher prices than other products, believing that their symptoms will be relieved.
Manufacturers of over-the-counter products such as health products giants Procter & Gambel along with Johnson & Johnson and its spinoff Kenvue, and retailers such as Walgreens may be facing numerous lawsuits which claim that the companies knew that phenylephrine was ineffective and did not work as advertised. The companies have been accused of knowing about the ineffectiveness of phenylephrine since as early as 2007 but continuing to make false and deceptive claims.
People who purchased oral products containing phenylephrine may have bought and used more expensive products due to marketing claims, over time spending hundreds of dollars on treatments that did not work.
People who purchased certain brands of oral allergy, decongestant or cough and cold products containing phenylephrine may be eligible for compensation.