Xeljanz Lawsuit

Pfizer’s Xeljanz (tofacitinib), a drug used to treat patients with arthritis and ulcerative colitis, may be linked to higher risks of blood clots, serious heart-related problems, and cancer.

Xeljanz Lawsuit

Pfizer’s Xeljanz (tofacitinib) is a drug used to treat patients with arthritis and ulcerative colitis. The safety profile of Xeljanz has been updated over the years to reflect evolving knowledge about possible adverse reactions. Warnings for an increased risk of blood clots and death were added to Xeljanz in 2019, and in 2021, the FDA warned about an increased risk of serious heart-related problems and cancer from Xeljanz. These risks were revealed in post-marketing safety studies conducted after the drug was already on the market. 

Xeljanz was prescribed to hundreds of thousands of patients over nearly a decade before these new safety issues were revealed to the public. In the meantime, Pfizer spent many millions of dollars marketing the drug and reaped billions of dollars in profits from it. Some Xeljanz patients are alleging in lawsuits that Pfizer had a legal duty to warn about these side effects earlier, and that the company's failure to do so caused them harm. After all, if Xeljanz was considered risky enough to require additional safety studies, didn’t doctors and patients deserve to have all the facts?  

Attorneys for ClassAction.com are filing lawsuits on behalf of clients who took Xeljanz and have been diagnosed with cancer, a major adverse cardiovascular event, or venous thromboembolism (such as a pulmonary embolism or deep vein thrombosis). To speak with our Xeljanz lawyers about a lawsuit, please contact us.

Xeljanz Uses Expand, Profits Grow

Xeljanz gained initial FDA approval in 2012 for the treatment of rheumatoid arthritis. Over the next eight years, Xeljanz was approved for three additional uses: psoriatic arthritis (2017), ulcerative colitis (UC) (2018), and polyarticular juvenile idiopathic arthritis (2020).

With new approved uses came a strong advertising push and rising sales. From 2014 to 2018, Xeljanz’s share of the rheumatoid arthritis market grew from 1% to 4%, according to Forbes. The new indication for UC resulted in 2019 global sales of $2.24 billion—an increase of 29% over 2018, reports Fierce Pharma. Pfizer spent more than $85 million on just one TV commercial in 2019 as it entered the UC space. Xeljanz generated sales of more than $1.7 billion in the first nine months of 2020 and around $2.4 billion for the year.

Xeljanz sales are expected to peak at around $3 billion in 2025 before the drug loses patent protection in 2026. Pfizer has total drug sales of around $50 billion per year.

Post-Marketing Study Reveals Severe Xeljanz Side Effects

Using clinical study data, the FDA evaluates a drug for both safety and efficacy when deciding whether to approve it. But the FDA can also order clinical studies known as “post-marketing studies” to be conducted after a drug is approved. The FDA did this with Xeljanz after it first approved the drug in 2012, ordering the ORAL Surveillance post-marketing study to evaluate the safety of tofacitinib with respect to major cardiovascular adverse events, malignancies, and other safety issues. Results from the study show that Xeljanz is more dangerous than previously known.

Xeljanz and Blood Clots

Based on results from the ORAL Surveillance study, in 2019 theFDA announced its approval of new Xeljanz warnings about thrombosis and death.

Pfizer stated in a press release that thrombosis (the blockage of a vein or blood vessel by a blood clot), including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, have occurred in patients treated with Xeljanz.

  • A pulmonary embolism is a blood clot that travels to the lungs.
  • A deep vein thrombosis is a blood clot in a deep vein, usually in the legs.
  • An arterial thrombosis is a blood clot in an artery that can top blood from reaching organs.

Xeljanz and Major Cardiovascular Events

The latest results from the ORAL Surveillance study were released in early 2021. They led to an FDA safety communication about increased risk of serious heart-related problems, or “major adverse cardiovascular events” (MACE).

Pfizer reported 135 patient subjects with MACE. The most frequently reported such event was myocardial infarction (heart attack), but the full data has not yet been released. Other major cardiac events that may be linked to Xeljanz include:

  • Acute coronary syndrome
  • Atrial fibrillation
  • Cardiac arrest
  • Cardiovascular death
  • Heart failure
  • Ischemic stroke

Xeljanz and Cancer

One of the purposes of the ORAL Surveillance study was to examine the risk of malignancies from Xeljanz—and the findings are concerning. A total of 164 patients (out of 4,362 total patients) in the study developed malignancies. That works out to approximately 1 in 26 Xeljanz patients diagnosed with some type of cancer.

Across all Xeljanz clinical studies and the post-marketing study, a number of different cancers have been observed in patients, including (but not limited to):

  • Breast cancer
  • Lung cancer
  • Lymphoma
  • Melanoma
  • Pancreatic cancer
  • Prostate cancer

Receive a Free Xeljanz Lawsuit Review

Should Pfizer have proactively updated Xeljanz warning labels years earlier? Did patients suffer preventable harm due to inadequate product warnings? What, exactly, did Pfizer know and when did it know it?

These are among the questions being raised in Xeljanz lawsuits. Our lawyers are investigating these issues and filing lawsuits to hold Pfizer accountable. As the largest personal injury law firm in the country, we have the resources to take on big drug companies like Pfizer—a company valued at nearly $220 billion. 

We have more than 700 attorneys and have recovered over $9 billion for our clients. Let us use our strength to help you. If you took Xeljanz and developed cancer, thrombosis, or heart-related issues, you may qualify for a lawsuit that can provide compensation for medical bills, lost wages, pain and suffering, and more. Learn more during a free case review.

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