Xeljanz Lawsuit
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Xeljanz Health Risks and Lawsuits
In February 2019, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication alerting physicians and patients that a manufacturer sponsored clinical trial found an increased risk for serious blood clot related injuries including pulmonary embolism and death in patients using a 10 mg twice daily dose of Xeljanz. Only two years later in February 2021, the FDA announced that further clinical trials results demonstrated an increased risk for cancer and serious cardiovascular adverse events including heart attack and stroke in patients using Xeljanz at any dosage compared to competitor medications. With these announcements, Pfizer, Inc., the manufacturer of Xeljanz, has been required to add a Black Box Warning to the drug’s label warning of these serious health risks.
What is Xeljanz and Why is It Prescribed?
Xeljanz and Xeljanz XR are the brand name for tofacitinib. Xeljanz was first approved by the FDA in November 2012 for the treatment of patients with rheumatoid arthritis who did not respond sufficiently to methotrexate therapy. The FDA later approved Xeljanz for additional indications including the treatment of psoriatic arthritis and ulcerative colitis. Xeljanz is manufactured and sold in the U.S. by Pfizer, Inc.
Xeljanz is available in 5 mg and 10 mg immediate release tablets as well as an 11 mg extended-release tablet. There is currently no generic equivalent for Xeljanz.
Xeljanz belongs to a class of drugs known as Janus kinase inhibitors or JAK inhibitors. JAK inhibitors are prescribed to treat inflammatory conditions. JAK inhibitors work by decreasing the activity of the body’s immune system. Other medications in the JAK inhibitor class include Olumiant and Rinvoq.
Over the last 8 years, Xeljanz has been prescribed to over 208,000 adult patients worldwide. Xeljanz has become a blockbuster drug for Pfizer, Inc. earning the company over $7 billion in sales revenue from 2013-2019.
Xeljanz Related Injuries
Multiple Pfizer-sponsored clinical trials have found that Xeljanz is linked to a number of serious and potentially life-threatening injuries. Xeljanz related injuries can include:
- Heart attack
- Stroke
- Pulmonary embolism (PE)
- Deep venous thrombosis (DVT)
- Blood clots
- Breast cancer
- Lung cancer
- Prostate cancer
- Lymphoma
- Non-Hodgkin’s lymphoma
- Other cancers
- Death
Xeljanz Litigation and Lawsuits
Given the number of adverse events involving Xeljanz that have been reported to the FDA and the new Black Box Warning regarding the risk of cardiovascular injuries and cancer, we anticipate that Xeljanz lawsuits will begin to be filed against Pfizer, Inc. in late 2021. As is common in prescription drug injury litigations, we expect Plaintiffs will allege that their use of Xeljanz has caused significant and permanent injuries and that Pfizer, Inc. designed and manufactured a defective medication while failing to provide adequate warnings about the medication’s serious health risks. The Xeljanz lawsuits will likely also contend that Pfizer, Inc. did not conduct adequate pre-market clinical trials or post-market pharmacovigilance to detect the safety issues with Xeljanz.
Xeljanz lawsuits will seek significant compensation for injured patients including medical expenses, lost wages or earning capacity, pain and suffering, disability, permanent injury, and death.
Maine Xeljanz Lawsuit & Settlement Lawyer
If you or someone you love has been prescribed Xeljanz and suffered a heart attack, stroke, pulmonary embolism (PE), deep venous thrombosis (DVT), or cancer, you may be entitled to significant compensation for your injuries, including reimbursement of medical expenses, lost wages, pain and suffering, disability and permanent injury, punitive damages, and wrongful death.
To speak with an experienced prescription drug injury attorney, contact Fitzgerald Law Group at (844) FITZ-LAW or (207) 874-7407, or complete the Case Evaluation Form on this website for a free, confidential, case assessment.
