Xeljanz is a prescription drug used to treat adults with the following conditions:
- Severely active rheumatoid arthritis
- Psoriatic arthritis
- Ulcerative colitis
An overactive immune system contributes to arthritis and colitis. Xeljanz (Tofacitinib) works by decreasing the activity of the immune system.
Xeljanz is manufactured by Pfizer Inc., an American multinational pharmaceutical corporation.
FDA Drug Safety Communication Warning on Xeljanz
On July 26, 2019, The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) approved new warnings about an increased risk of blood clot complications and death with a 10 mg twice daily dose of Xeljanz (Tofacitinib), prescribed for patients with ulcerative colitis.
The January 2019 initial safety trial results found the following:
- A higher rate of clots in the lung in arthritis patients who received tofacitinib at 10 mg twice daily, compared to patients treated with tumor necrosis inhibitor (TNF) blockers by healthcare professionals
- A greater number of deaths from all causes in arthritis patients who received tofacitinib at 10 mg twice daily, compared to patients who received TNF blockers.
The FDA issued this safety study as part of the approval process for Xeljanz in 2012. Only the 5 mg once or twice daily dose of Xeljanz is approved for rheumatoid arthritis, but a 10 mg twice daily dose is approved for ulcerative colitis.
Clinical Trials Link Xeljanz to Blood Clot Risks in the Lungs
In a post-marketing study, Xeljanz was found to dramatically increase the risk of a blood clot developing and then traveling to the lungs to cause a pulmonary embolism, especially when taken at a high dose.
The study looked at 4,400 test subjects, all of whom have at least 2 cardiovascular events, and was designed to compare the efficacy and safety of Xeljanz to a tumor necrosis factor inhibitor drug in people with rheumatoid arthritis.
The trial aimed to find out whether Xeljanz was more or less safe for people who have increased risk for a major adverse cardiovascular event, and monitored their heart health and whether they developed malignancies, serious infections or lung cancer.
Pfizer intervened in the study on February 19, 2019, to take participants off of the twice-daily dose of 10 milligrams. The decision was made after Pfizer was notified by the Rheumatology Data Safety Monitoring Board that a high number of participants in that dosage level were developing clots in their lungs and suffering pulmonary embolisms and serious infections.
People taking the high dosage of Xeljanz were suffering pulmonary embolisms more than five times as often as people taking the tumor necrosis factor inhibitor drug. They were also suffering pulmonary embolisms three times as often as other Xeljanz participants in that trial and others like it.
Pfizer’s announcement was likely spurred by the FDA’s announcement about Xeljanz in February 2019, which warned the public of the potential for a blood clot reaching the lungs after taking the drug.
See all related dangerous drug lawsuits our lawyers have covered.
- Blood clots in the lungs
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- Non-melanoma skin cancer
- Lung cancer
- Other cancers
- Heart attack
- Cardiovascular risk factor
- Major cardiac events
- High blood pressure
- Ulcerative colitis
- Serious infections
- Sinus infections
- Immune system problems
- Chronic inflammatory conditions
- Extrapulmonary tuberculosis
- Invasive fungal infections
- Jaundice (yellowing of the eyes and/or skin)
- Breath chest pain
- Sudden shortness of breath
- Skin rash
- Cardiovascular death
- Other adverse events
Timeline of Events Related to Xeljanz Blood Clots Lawsuits
- February 25, 2019: Increased Risk of Xeljanz and Blood Clots in Lungs - The FDA warned patients that a safety clinical trial of Xeljanz demonstrated a heightened risk of clots in the lungs (pulmonary embolism) and heart attack. The risk applied to patients who took 10 mg twice-daily for treatment of rheumatoid arthritis (RA) blood clotting. This dose had been approved only for the treatment of ulcerative colitis, not for RA patients. Pfizer responded by transitioning its RA patients who were on the twice-daily 10 mg dose to a 5 mg dose twice-daily.
- July 26, 2019: Xeljanz Black Box Warning - FDA issued a statement indicating that the agency had not only approved warnings regarding Xeljanz, but that it had also added a Black Box Warning, the strongest warning allowed by law. The Black Box warning conveyed the dangers of using the 10 mg twice-daily dose for rheumatoid arthritis and also stated that the risk of clots, heart attack and death could also apply to patients taking Xeljanz for ulcerative colitis.
- February 4, 2021: Serious Heart Problems and Cancer - FDA Drug Safety Communication published warning the public of the results from a safety clinical trial which found an increased risk of lung cancer and serious heart-related problems with Xeljanz. The trial also looked at other potential risks of taking Xeljanz, including clots in the lungs and death.
- September 1, 2021: Serious Heart-Related Events, Cancer, Blood Clots, and Death - "Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, [the FDA] concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz (tofacitinib)."
What is a Blood Clot?
Blood clots are gel-like collections of blood that form in a person's veins or arteries when blood changes from liquid to partially solid. Clotting is a normal function that stops the body from bleeding too much when you get hurt. However, blood clots that form in some places and don’t dissolve on their own can be dangerous to your health.
When a blood clot forms where it should not have developed, it is called a thrombus. The clot may stay in one spot (called thrombosis) or move through the body (called embolism or thromboembolism). The clots that move are especially dangerous. Blood clots can form in arteries (arterial clots) or veins (venous clots).
Blood Clot Symptoms
Deep Vein Thrombosis DVT Symptoms
- Redness of the skin
Pulmonary Embolism Symptoms
- Difficulty breathing
- Faster than normal or irregular heartbeat
- Chest pain or discomfort, which usually worsens with a deep breath or coughing
- Coughing up blood
- Very low blood pressure, lightheadedness, or fainting
Treatment for blood clots depends on where the clot is in the body, and the severity of the condition. Blood-thinning medications are commonly used to prevent blood clots from forming or getting bigger. Thrombolytic medications can break up existing clots.
Catheter-directed treatments, such as percutaneous transcatheter treatment, are done by inserting a catheter into a blood vessel in the groin. The tube is moved to the site of the clot and used to break up the clot or deliver clot-dissolving thrombolytic dangerous drugs directly.
Surgical thrombectomy, in which the clot is surgically removed from the vein or artery, is often used in arms or legs, but can be used elsewhere in the body.
For patients who are at high risk of developing a life-threatening deep vein thrombosis, immediate medical attention should be considered. In addition to or instead of blood thinners, intermittent pneumatic compression (IPC) devices can be very effective. A cuff is placed around the leg, where it periodically fills with air and squeezes, helping move blood toward the heart.
What are Xeljanz Blood Clots Lawsuit Alleging?
Our law firm is now accepting lawsuits on behalf of patients who experienced a life-threatening venous thromboembolic event (VTE) such as a PE (a blood clot in the lungs) or a DVT (a blood clot in the deep veins of the body, usually the legs) after taking Xeljanz for rheumatoid or psoriatic arthritis, or for colitis.
DVTs and PEs can be dangerous, and even fatal. The labels for these medications do not presently warn of this risk.
If you or a loved one suffered from a blood clot after taking any dose of Xeljanz for ulcerative colitis, rheumatoid arthritis, or psoriatic arthritis, please reach out today for a free consultation. We can help you explore your legal options. You may be able to seek compensation for your injuries, including medical expenses, lost wages, and pain and suffering.
The law firm of Schmidt & Clark, LLP, has a Drug and Medical Device Litigation Group with attorneys who have decades of experience in complex pharmaceutical litigation.
Liability Law in Pfizer Xeljanz Blood Clots Lawsuits
Under most state laws, a patient injured through the use of a defective drug or medical devices can bring a Xeljanz blood clots lawsuit against drug companies based on the following legal theories:
- Design Defect: When a drug is manufactured per design specifications, but the design itself renders the drug ineffective or unsafe;
- Manufacturing Defect: When a drug is safely designed, but has a defect through the manufacturing process, rendering it dangerous or unsafe; and/or
- Failure to Warn: When the drug manufacturer fails to warn the public of the risks or to provide adequate instructions about the use of the drug, thereby rendering it unsafe or dangerous.
All states enforce a statute of limitations that limits the amount of time you have to file a Xeljanz blood clots lawsuit against a drug manufacturer. A member of our legal team can inform you of your state’s laws.
Get a Free Xeljanz Blood Clots Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial attorneys that focus on the representation of plaintiffs in Xeljanz blood clots lawsuits. We are handling individual litigation nationwide and currently accepting new blood clot injury and death cases in all 50 states.
Free Xeljanz Blood Clots Lawsuit Evaluation: Again, if you developed a blood clot (pulmonary embolism, deep vein thrombosis, etc.) after taking Xeljanz to treat rheumatoid arthritis, you should contact our attorneys immediately. Xeljanz patients may be entitled to compensation for medical expenses by filing a Xeljanz blood clots lawsuit and our attorneys can help.