Did you or a loved one suffer complications after taking Xeljanz or Xeljanz XR? According to the FDA, Xeljanz® (tofacitinib) can increase risks of blood clots and death when prescribed at 10 mg, twice-per-day doses in patients with rheumatoid arthritis (RA). Pfizer, Xeljanz’ drug maker, is now transitioning patients on 10mg twice-a-day doses to a dose of 5 mg twice daily as required by the FDA.
Patients who experienced complications after using the unapproved 20 mg / day dose of Xeljanz (10 mg twice per day) may have the right to seek compensation for their damages. That includes medical expenses, lost wages, pain and suffering, and other emotional and economic losses victims and their families may have suffered due to injuries or the tragic, untimely death of a loved one.
Bailey Cowan Heckaman PLLC is reviewing potential Xeljanz claims from patients and families nationwide involving blood clots (thrombosis), pulmonary embolism, and wrongful death.
Why Bailey Cowan Heckaman PLLC?
- National Trial Lawyers With 150+ Years’ Experience
- Proven Results in Product & Pharmaceutical Liability
- Contingency Fees – No Fee Unless We Win
BCH is a Texas-based Trial Law Firm known nationally for handling complex product and pharmaceutical liability claims against powerful corporations that put profits over people.
Call (713) 909-7910 or contact us online to speak with an attorney about a potential case anywhere in U.S.
FDA Links Xeljanz to Risks of Blood Clots & Death
On February 25, 2019, the U.S. Food and Drug Administration (FDA) released a safety announcement warning the public about increased risks of blood clots and death associated with Xeljanz – specifically among patients who use the medication to treat rheumatoid arthritis. The safety announcement noted:
- Increased Risks – A clinical trial found a 10 mg, 2x daily dose of Xeljanz or Xeljanz XR for patients with rheumatoid arthritis (RA) posed greater risks of blood clots in the lungs (pulmonary embolism) and death compared to a lower (5 mg , 2x daily) dose or a TNF inhibitor.
- Higher Dose Not Approved – The FDA has not approved the 10 mg, 2x daily dose for rheumatoid arthritis (RA). This dose is only approved for treating patients with ulcerative colitis.
- Pfizer Required to Lower Dose – As part of the ongoing safety trial, the FDA has required Pfizer to transition any patients taking the higher 10mg / 2x day dose of Xeljanz to a lower dose of 5 mg, 2x day. It has also warned doctors and patients.
Because there are risks associated with abruptly stopping tofacitinib, any patient taking a 10 mg, twice daily dose of Xeljanz should speak to their doctor. Patients are also being advised to seek immediate medical attention if they experience any signs of blood clots, including:
- Breathing difficulties
- Sudden shortness of breath
- Chest pain or back pain
- Sweating excessively
- Clammy and / or discolored skin
- Coughing up blood
Xeljanz Lawsuit: Do You Have a Case?
You may have a potential Xeljanz lawsuit if you or someone you love took Xeljanz or Xeljanz XR, and suffered adverse health events such as:
- Pulmonary Embolism (PE)
- Pulmonary Thrombosis
- Deep vein Thrombosis (DVT)
- Portal Vein Thrombosis (PVT)
- Thrombosis
- Death
BCH is actively reviewing potential cases from patients and families across all 50 states who suffered these and other adverse events after taking Xeljanz. During a FREE and confidential case review, we can closely examine your case to determine your rights and options.
Xeljanz & Clinical Safety Trial
Xeljanz (tofacitinib) is part of a newer class of drugs known as JAK inhibitors. First approved by the FDA in 2012 to treat rheumatoid arthritis – a condition where the body itself attacks joints, causing swelling, pain, and loss of function – the medicine works by decreasing immune system activity.
Tofacitnib is currently approved by the FDA for several treatment purposes:
- Rheumatoid arthritis (FDA approved in 2012);
- Psoriatic arthritis in patients for whom methotrexate or similar medications known as DMARDs did not work (2017); and
- Ulcerative colitis (2018).
When the FDA first approved tofacitinib, it required Pfizer to conduct clinical safety trials to evaluate adverse health risks among patients with RA taking the medication at two different doses (10 mg 2x daily, and 5 mg 2x daily). Study participants were 50 years of age or older, and had at least one cardiovascular risk factor, such as high blood pressure.
February 25, 2019’s FDA Safety Announcement was issued following the most recent analysis of the safety trial. In that analysis, a committee found increased occurrences of pulmonary embolism among patients taking the higher dose of tofacitinib, as compared to those treated with the lower dose or a TNF (tumor necrosis factor) inhibitor. The study is still ongoing, but the FDA is actively issuing warnings.
BCH: Proven National Pharmaceutical Liability Lawyers
Bailey Cowan Heckaman PLLC is a nationally recognized Civil Trial Law Firm with a proven record in highly complex and high-stakes personal injury and wrongful death claims involving defective products, medical devices, class actions / mass torts, and pharmaceutical drugs. We know victims and families can suffer tremendously when Big Pharma prioritizes its bottom line over patient safety – and we are passionate about fighting for the justice and compensation victims deserve.
Call (713) 909-7910 or contact us online to speak with an attorney. BCH serves clients nationwide and offers FREE consultations. There are no costs to working with our firm, and no fee unless we win.
