Xeljanz Lawsuit

The pharmaceutical company Johnson & Johnson has been hit with a lawsuit from consumers who claim that their new drug, Xeljanz, is not safe for use. The claims have not yet been proven in court and the outcome affects many other similar drugs as well.

The “xeljanz complaints” is a lawsuit that has been filed against Pfizer. The lawsuit alleges that the drug company marketed xeljanz for uses not approved by the FDA.

The medicine Xeljanz (tofacitinib) from Pfizer is used to treat arthritis and ulcerative colitis. Xeljanz’s safety profile has been revised throughout time to reflect new information concerning potential side effects. In 2019, the FDA added warnings to Xeljanz regarding an increased risk of blood clots and mortality, and in 2021, the FDA cautioned about an increased risk of significant heart-related disorders and cancer from Xeljanz. These dangers were discovered after the medicine was already on the market, in post-marketing safety investigations. 

Hundreds of thousands of patients were administered Xeljanz over the course of almost a decade before these new safety concerns were made public. Meanwhile, Pfizer spent hundreds of millions of dollars on promoting the medicine and made billions of dollars from it. In litigation, some Xeljanz users claim that Pfizer had a legal obligation to tell them about these adverse effects sooner, and that the company’s refusal to do so caused them injury. After all, if Xeljanz was deemed dangerous enough to warrant extra research, didn’t physicians and patients need to know everything?  

Clients who took Xeljanz and were diagnosed with cancer, a significant adverse cardiovascular event, or venous thromboembolism are being represented by attorneys at ClassAction.com (such as a pulmonary embolism or deep vein thrombosis). Please contact us if you would want to discuss a case with one of our Xeljanz attorneys.

Xeljanz’s Uses Expand, and Profits Increase

In 2012, the FDA approved Xeljanz for the treatment of rheumatoid arthritis. Xeljanz was authorized for three more indications over the following eight years: psoriatic arthritis (2017), ulcerative colitis (UC) (2018), and polyarticular juvenile idiopathic arthritis (2020).

With the addition of additional permitted uses, there was an increase in advertising and sales. According to Forbes, Xeljanz’s share in the rheumatoid arthritis market increased from 1% to 4% between 2014 and 2018. According to Fierce Pharma, the new indication for UC led in worldwide sales of $2.24 billion in 2019, up 29 percent from 2018. In 2019, Pfizer spent more than $85 million on a single TV ad to promote its entry into the UC market. Xeljanz made about $1.7 billion in sales in the first nine months of 2020, and over $2.4 billion for the whole year.

Before the drug’s patent expires in 2026, sales of Xeljanz are estimated to reach over $3 billion in 2025. Pfizer’s annual medicine sales are estimated to be approximately $50 billion.

The Results of a Post-Marketing Study Xeljanz Side Effects Are Severe

When considering whether or not to approve a medicine, the FDA looks at clinical research data to assess its safety and effectiveness. However, once a medicine is authorized, the FDA might mandate clinical investigations known as “post-marketing studies.” After originally approving Xeljanz in 2012, the FDA ordered the ORAL Surveillance post-marketing research to assess the safety of tofacitinib in terms of significant cardiovascular adverse events, malignancies, and other safety concerns. According to the findings, Xeljanz is more harmful than previously thought.

Blood Clots and Xeljanz

Based on the findings of the ORAL Surveillance research, the FDA approved additional Xeljanz warnings regarding thrombosis and mortality in 2019.

Thrombosis (blockage of a vein or blood artery by a blood clot), including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, has been reported in individuals treated with Xeljanz, according to Pfizer.

  • A blood clot that goes to the lungs is known as a pulmonary embolism.
  • A blood clot in a deep vein, commonly in the legs, is known as a deep vein thrombosis.
  • An arterial thrombosis occurs when a blood clot forms in an artery, preventing blood from reaching vital organs.

Major Cardiovascular Events and Xeljanz

The ORAL Surveillance study’s most recent findings were announced in early 2021. They prompted the FDA to issue a warning regarding an elevated risk of significant heart issues, known as “major adverse cardiovascular events” (MACE).

Pfizer reported 135 MACE patient participants. Myocardial infarction (heart attack) was the most often reported such incident, although the entire data has yet to be revealed. Other significant cardiac incidents connected to Xeljanz include:

  • Acute coronary syndrome (ACS) is a kind of heart attack that occurs
  • Atrial fibrillation is a condition in which the heart beats irregularly
  • Arrest of the heart
  • Death due to cardiovascular disease
  • Insufficiency of the heart
  • Ischemic stroke is a kind of ischemic stroke.

Cancer and Xeljanz

One of the goals of the ORAL Surveillance project was to look into the risk of Xeljanz-related cancers, and the results were alarming. In the trial, 164 participants (out of a total of 4,362 subjects) got cancer. This equates to around one in every 26 Xeljanz patients being diagnosed with cancer.

A variety of malignancies have been reported in participants throughout all Xeljanz clinical trials and the post-marketing study, including (but not limited to):

  • Breast cancer is a kind of cancer that affects
  • Lung cancer is a kind of cancer that affects the
  • Lymphoma
  • Melanoma
  • Pancreatic carcinoma is a kind of cancer that affects the pan
  • Prostate cancer is a kind of cancer that affects men

Get a Free Xeljanz Lawsuit Analysis

Shouldn’t Pfizer have revised the Xeljanz warning labeling years ago? Were patients harmed as a result of insufficient product warnings? Pfizer knew precisely what it knew and when it knew it.

These are some of the concerns cited in the Xeljanz litigation. Our attorneys are looking into these allegations and are preparing litigation to hold Pfizer responsible. We have the resources to take on giant pharma firms like Pfizer—a business worth over $220 billion—as the country’s biggest personal injury legal practice. 

We have over 700 lawyers on staff and have helped our clients collect over $9 billion in damages. Let us put our might to work for you. If you took Xeljanz and had cancer, thrombosis, or heart problems, you may be eligible for reimbursement for your medical costs, lost earnings, pain and suffering, and other expenses. During a free case review, you may learn more.


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The “xeljanz shingles” is a lawsuit that has been filed against Pfizer Inc. The plaintiff in the case is seeking to recoup costs of the treatment for shingles, which was prescribed by doctors who were not informed of the risks associated with xeljanz.

Frequently Asked Questions

Are there any lawsuits against Xeljanz?

A: I have no idea what you are talking about.

Is Xeljanz being recalled?

A: Not at all. Xeljanz is not being recalled, its just that the brand name of the drug has changed. The new brand name for this medication is now tofranil.

Has anyone died from Xeljanz?

A: As of now, no deaths have been caused by Xeljanz.

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