Millions of dollars of OTC (over-the-counter) cold, decongestion, and allergy medications are sold in the United States each year. The active ingredient in one type of oral medication, found in brands like Sudafed PE and Vicks Nyquil, is phenylephrine. To gain FDA approval, these medications must be considered Generally Recognized as Safe and Effective (GRASE). While the former is arguably more important than the latter, it’s clear that people will wish to know that their medication is effective as advertised. Unfortunately, according to the latest data and FDA advice, the medication simply does not work. A unanimous decision by an FDA panel found oral phenylephrine nasal decongestants to be ineffective, even when given in high doses. The decision, which reviews the original FDA approval for this type of oral medication, has raised anger among users, particularly as concerns have been raised as to the effectiveness of phenylephrine oral medication for several years now, with some groups arguing it is no more effective than a placebo. Numerous pharmaceutical brands sell OTC products containing phenylephrine as the key ingredient, and they may face lawsuits on behalf of consumers.

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Across September 11^th-12^th, 2023, the FDA held meetings of the Drug Advisory Committee, which unanimously advised that OTC oral cough and cold products that use phenylephrine as an active ingredient were ineffective. Citing the latest scientific data, the Drug Advisory Committee was unequivocal on the issue. Soon after, nationwide class-action lawsuits were filed against pharmaceutical companies, including Johnson & Johnson and Proctor & Gamble, who manufacture and market these products. Right now, phenylephrine lawyers are asking people to come forward to join the class actions to pursue compensation.

• November 1, 2023 - The future of phenylephrine is uncertain. An FDA committee has said that it's ineffective, and a class-action lawsuit claims false advertising. What happens next could have major repercussions.

Phenylephrine is the key ingredient in a range of cold, cough, allergy, and other decongestant medications. Sometimes, it is used in conjunction with other ingredients, such as ibuprofen. Phenylephrine can actually be used to treat a range of issues, ranging from treating hemorrhoids to increasing blood pressure. However, it is mainly known for its role in uncomplicated nasal decongestion treatment, i.e., as a remedy for symptoms of the common cold and similar ailments. While patented back in 1927, phenylephrine’s widespread use as a key ingredient in OTC cold medications came about more recently, as it replaced pseudoephedrine, a medication that was largely banned from OTC sales due to its role in the manufacturing of illegal drugs (methamphetamines). Since 2006, when pseudoephedrine was banned as an OTC medication ingredient, phenylephrine has been more common. The upshot for the current phenylephrine medication lawsuits is that people will have been buying this medication for over 15 years while not being informed that it was ineffective.

Decongestant drugs are among the most commonly sold OTC medications in the United States. Those oral medications that contain phenylephrine as the key ingredient are manufactured by many different companies under different brand names. The brands include:

• Alka-Seltzer Plus Cold
• Alka-Seltzer Plus Multi-Symptom
• Alka-Seltzer Plus Severe Allergy
• Benadryl Allergy Plus Congestion
• Comtrex
• Delsym Multi- Symptom
• Mucinex Sinus Max
• Mucinex Fast- Max
• Mucinex Free From Cold & Flu
• Mucinex Nightshift
• Mucinex Nightshift Sinus
• Neocitran
• Norel AD
• Robitussin Multi-Symptom
• Sudafed PE
• Theraflu Severe Cold & Cough
• Tylenol Cold and Flu
• Tylenol Cold Multi-Symptom
• Tylenol Cough and Cold
• Tylenol Sinus
• Vicks DayQuil
• Vicks Nyquil
• Vicks QlearQuil
• Vicks Sinex

The above brands are owned and marketed by top pharmaceutical companies like Bayer, Proctor & Gamble, and Johnson & Johnson. If you have purchased any of these products, you may be eligible to join the phenylephrine class action lawsuits.

While all medications can have side effects, there is nothing in the FDA report to suggest that phenylephrine products are harmful. As such, the idea behind a class action lawsuit is for claimants to recoup the money lost on the products that, in this case, are deemed to be ineffective. Of course, it is always possible that more information will come to light, which could act to increase the phenylephrine compensation settlements. The good news for potential claimants is that class action lawsuits are easy to join and require little effort on your part. So, if you think you are eligible, you can sign up to join the lawsuits in a few minutes.

The Drug Advisory Committee is a board that provides independent recommendations to the FDA. Thus, it is important to note that this decision has not been made by the FDA, nor is it yet considered a ruling. However, the FDA rarely deviates from advice handed down by the Drug Advisory Committee, so it is more than likely that the GRASE ratings will be removed from OTC oral phenylephrine cold and cough products. Indeed, it is possible that the products are removed from the market altogether. The Committee’s advice came on the back of new data that showed the phenylephrine used in these products was metabolized in the liver and gut before reaching the bloodstream, and only a small fraction, if any, would reach the nasal area to combat the congested areas. The effectiveness of phenylephrine itself is not in question, and the FDA has maintained that phenylephrine nasal sprays are still effective. It is the means of taking the medication – in tablet form – that renders OTC oral phenylephrine ineffective.

One of the main issues that will be addressed in the phenylephrine medication class action lawsuits is what the manufacturers knew about the efficacy of their products. As mentioned previously, studies have questioned the effectiveness of orally ingested phenylephrine products since the mid-2000s. The likes of Johnson & Johnson et al. claim to conduct rigorous testing of their products for safety and effectiveness before they make blatant claims about them in the marketplace. It is possible that these claims were deliberately misleading or false. Such considerations will be important in the upcoming lawsuits for ineffective phenylephrine products.

What are the issues with phenylephrine?

The main issue with phenylephrine-based oral medication is that it simply does not work, according to the latest studies and advice by the FDA Drug Advisory Committee.

How safe is phenylephrine?

The FDA maintains that phenylephrine remains safe for use. That said, all medications can have side effects. You should speak with your doctor if unsure.

Is phenylephrine approved by the FDA?

Currently, yes. The medications in question carry the FDA’s GRASE rating, which terms them Generally Recognizable as Safe and Effective. However, the medications may lose that rating after recent recommendations by the FDA Drug Advisory Committee.

Is phenylephrine an oral decongestant?

Not necessarily. Phenylephrine is the key ingredient in some oral decongestants. It can also be found in nasal sprays.

Is phenylephrine still used?

Yes. It has a range of medical uses. The issue of the phenylephrine lawsuits focuses on the ineffectiveness of phenylephrine-based tablets to treat cold symptoms. The drug itself has a range of medical uses.

What is the phenylephrine controversy?

Put simply: It does not seem to work in tablet form. Big pharmaceutical companies have made billions in selling OTC phenylephrine oral medication for years, and the latest findings suggest they are no more effective than a placebo.

Is phenylephrine recalled?

Not yet. The FDA still has to act on the advice of the independent Drug Advisory Committee. It is also possible that the drug companies decide to remove the products from the market. But no action has been taken yet.