Xeljanz Lawsuit

This page is about Xelijanz lawsuits. Our lawyers are handling Xelijanz side effects lawsuits in all 50 states.  Lawsuits allege this drug comes with the risk of serious cardiac and other side effects. This was confirmed by the FDA in September 2021.

Xeljanz is a popular medication that is prescribed to treat patients suffering from rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Xeljanz is the brand name for the drug Tofacitinib, which works by suppressing the patient’s immune system to help reduce inflammation in the body. Since its original release in 2012, this medication has exploded in popularity because of its placement of ads on television and in magazines.

November 9, 2023 Update: A new study has revealed that Xeljanz and similar medications used for treating inflammation and autoimmune conditions, such as ulcerative colitis and rheumatoid arthritis, may elevate the risk of developing acne. Harvard researchers have reported that patients taking Janus Kinase (JAK) inhibitors, which include popular treatments like Xeljanz and Rinvoq, were found to be four times more likely to experience acne when compared to those not utilizing such medications.

Specifically, patients taking JAK1 inhibitors like Imbruvica and Zydelig faced nearly five times the risk of developing acne, while those taking a combination of JAK1 and JAK2 inhibitors like Rinvoq and Xeljanz faced a nearly four-fold increase in acne.

Will there be Xelijanz acne lawsuits?  Probably not.  But the point is that we do not fully understand all of the side effects of these drugs.

June 30, 2023 Update: We are not aware of any new Xeljanz lawsuits that were filed in the last year.  This litigation does not appear to have legs.

August 25, 2022 Update: The bad news continues to mount for Xeljanz. With concerns about heart problems, blood clots, and cancer already swirling, a new study came out last week indicating that increased risk of infection may be yet another dangerous side effect associated with Xeljanz. The study in the Annals of the Rheumatic Diseases reported that Xeljanz infection risks were twice as high as alternative drugs.

March 2022 Update: The medical literature continued to strengthen the plaintiffs’ case in the Zelijanz lawsuits. A Mayo Clinic study found higher adverse cardiovascular events and greater incidence of cancer with Xeljanz and other tumor necrosis factor (TNF) inhibitors (Remicade, Humira, Enbrel).

November 2021 Update: A study was published in the Journal of Clinical Radiology that concluded that all drugs in the new class of JAK inhibitors (which includes Xeljanz) seem to pose an inherent risk of serious adverse cardiovascular problems and blood clots. The study could not conclude whether the risk of blood clots or cardiovascular events was significantly higher for Xeljanz compared to other JAK inhibitors. The research team stressed the need for more comprehensive studies and clinical trials to better understand whether Xeljanz presents a higher risk of these problems than other drugs.

September 2021 Update: The FDA just confirmed that Xeljanz and Xeljans XR carry an increased cardiac risk for heart attack, stroke, blood clots, and can even cause cancer and death.  This is what plaintiffs’ lawyers have been saying with Xelijanz lawsuits for quite some time now.  This news, and the new warning that will come with this drug, is good for consumer safety – less people will die from this drug.  It is also good news for victims who have filed Xelijanz lawsuits. 

Manufactured by pharmaceutical giant Pfizer, the company has raked in over a billion dollars in profit off the hundreds of thousands of people use the drug. In February 2019, Pfizer was hit with an FDA safety warning that linked Xeljanz to an increased risk of blood clots in the lungs and overall death.  This has led many lawyers, including us, to investigate potential Xeljanz lawsuits.

Months later, Pfizer to put a black box warning on their drug label. This scares off doctors and patients. This is arguably why Pfizer did not suggest to the FDA adding this warning long ago.

Follow the money.  This warning is expected to put significant stress on the company’s profits as patients avoid the medication and file new failure to warn lawsuits. (The good news for Pfizer is that there warning will prevent many future lawsuits from being filed.)

What is Xeljanz?

Xeljanz is an oral medication that was originally developed to treat moderate to severe rheumatoid arthritis, however, since its release it has also been approved to treat psoriatic arthritis and ulcerative colitis.

How Long Has Xelijnz Been on the Market?

Pfizer first released Xeljanz onto the public market in 2012 after receiving FDA approval. Soon after the release, the company embarked on an intense mass marketing campaign to bring attention to their new drug. Pfizer invested in various types of advertisements, including on TV, in magazines, and on billboards.

The campaign was highly effective, and patients all around the country became interested in trying out the medication. They had a reason to be excited, too. Xeljanz is one of only two JAK inhibitor drugs (a class of medications that compresses the immune system) that have been approved to treat rheumatoid arthritis. It opened a new door for patients who did not respond well to methotrexate, another standard treatment for arthritis and colitis conditions.

Xeljanz Has Made a Fortune for Pfizer

In recent years, Pfizer’s success has only continued to grow. Between 2013 to 2018, doctors prescribed Xeljanz to around 132,000 people in the United States for rheumatoid arthritis. On top of that, Xeljanz is now approved in over 80 countries, drastically increasing Pfizer’s profits. In 2018 alone, the company brought in almost $2 billion dollars worldwide. It’s fair to say that Pfizer and Xeljanz have been dominating the pharmaceutical market.

How Is Xeljanz Used?

Xeljanz comes in two forms: Xeljanz instant-release and Xeljanz XR (extended-release). Both forms of Xeljanz contain the ingredient known as tofacitinib, which belongs to a class of drugs called JAK inhibitors. JAK inhibitors work by blocking the immune system’s ability to produce cytokine, a protein that plays a role in inflammation. This allows the immune system to calm down and help reduce swelling in the body. There are two dosages for Xeljanz, a 5mg or 11mg pill taken once or twice a day depending on the patient’s condition.

What Are the Side Effects of Zeljanz? 

JAK inhibitors like Rinvoq are not without side effects. The FDA mandated an additional safety trial for JAK inhibitor drugs, including Xeljanz and Xeljanz XR, and Olumiant manufactured by Eli Lilly and Company. These trials aimed to assess the risk of serious adverse effects associated with Xeljanz compared to non-JAK inhibitor anti-inflammatory drugs.  This led to the FDA seeing a link between tofacitnib usage and potentially fatal side effects like increased risk of blood clots in the lungs (pulmonary embolism).The FDA issued repeated warnings starting in February 2019, stating that certain dosages of Xeljanz were linked to elevated risks of heart-related issues, cancer, and other adverse events.

Back in 2012 when the FDA first approved Xeljanz for the public market, they also required a clinical trial to study the risk of heart-related events, cancer, and opportunistic infections for the 5mg and 11mg doses. They compared the treatment and risk factors of Xeljanz to another popular inhibitor drug that is often sold under the brand names of Humira, Remicade, and Enbrel.

The trial used subjects at least 50 years old and had at least one cardiovascular risk factor. Before the study could even be completed, researchers identified dangerous and possibly life-threatening side-effects of Xeljanz, which resulted in the FDA quickly publishing a safety warning for the medication.

The results of the study found that patients who are prescribed the highest dose of Xeljanz, 11mg taken twice a day, are at a significantly increased risk of pulmonary embolism (PE), deep-vein thrombosis (DVT), and death compared to the lower 5mg dose.

PE and DVT are blood clots that can develop in a person’s legs. Blood clots by themselves can be dangerous, but the real problem is when the clots grow big enough to break off in the body and travel to other organs.

With PE and PVT, the clot travels to the lungs and becomes stuck in an artery, blocking the passage of blood and oxygen. This creates a life-threatening situation that can be fatal if a person does not receive medical treatment in time.

The FDA continued its investigation into Xeljanz’s side effects over the next few months, but it wasn’t long until another statement was released. In February 2021, the FDA issued an alert warning that preliminary results from the now-complete ORAL Surveillance Trial “show an increased risk of serious heart-related problems and cancer with [Xeljanz] compared to another type of medicine called tumor necrosis factor (TNF) inhibitors.”

Utimately, the FDA approved a black box warning for Xeljanz, the strictest warning for drug labels in the US. Medications only receive black box warnings when there is reasonable evidence of a drug being associated with severe, life-altering side effects. This is the latest update of the Xeljanz investigation, but most likely not the last.

Is Enbrel a Safe Alternative to Xeljanz?

Xelijanz and Enbrel are both used by people who suffer from rheumatoid arthritis. But these are very different classes of drugs.  There are also concerns with Enbrel. There are indications that Enbrel increases the risk of tuberculosis and fungal infections.

Is Enbrel a better choice for you?  This is the wrong question for a lawyer and the right question for your doctor who should discuss all the risks and benefits of these drugs to you.

If you have already had this conversation with your doctor, you should talk to her again after what the FDA found in September 2021.

Xeljanz Blood Clot Lawsuits

Following the release of the safety warning in February, Pfizer immediately began to feel the repercussions of the study’s findings. Patients became outraged with the company and doctors avoided prescribing Xeljanz due to bad publicity.

It’s expected that there will be a dramatic increase in Xeljanz-related lawsuits within the next year, which has the potential of putting a serious dent into Pfizer’s profits from being forced to shell out large sums of settlement money.

These new lawsuits will center on the fact that Xeljanz’s drug label did not include blood clots as a potential side-effect until the FDA required it in July 2019.

Patients took this medication for years without knowing the real effects it could have.

This might meet the requirements for a “failure to warn” case, meaning Pfizer did not provide a clear warning or set of instructions for the proper use of their medication.

To prove this case, one of the key components is showing that Pfizer was aware of the dangerous side effects but sold it, anyway. Patients filing lawsuits believe they may have some evidence to support this claim. Before the FDA released its first safety warning, there were already reports submitted to the FDA Adverse Event Reporting System (FAERS) by people saying they experienced PE or DVT while taking Xeljanz.

Despite the growing amount of reports, Pfizer continuously denied the connection and refused to take action to investigate further. It wasn’t until the FDA’s report that Pfizer agreed to start transitioning patients onto lower doses. Some of these outraged patients believe that Pfizer already knew there was an ongoing issue with their medication but intentionally refused to address the problem out of fear it would hurt their business.

Patients seeking to hold Pfizer liable for their injuries will most likely need to show:

• That they were being treated for arthritis or ulcerative colitis with Xeljanz or Xeljanz XR
• That they were prescribed an 11mg twice daily dosage
• They suffered from PE, DVT, or other serious blood clot injuries

The outlook for Pfizer and Xeljanz can be both good and bad.

The good news is that with the black box warning, newly injured patients will find it hard to file suit based on failure to warn claims. This means that there will eventually be an end to Xeljanz-related lawsuits.

The bad news is that Pfizer has already lost a significant amount of support from both doctors and patients. Additionally, there may be future safety warnings released once there are final results from ongoing clinical trials.

Is There a Xeljanz Recall?

There is no recall and Xaljanz lawyers are not calling for a recall.  In fact, Pfizer has already fixed the warning.  But that is of little help for people who suffered cardiovascular side effects from Xeljanz who should have gotten a warning and did not get one.  This is what a Xeljanz lawsuit is about.