Xeljanz Side Effects Linked To Risk of Pulmonary Embolism, DVT, Blood Clots and Wrongful Death
The FDA is requiring Pfizer to add a new “black box” warning about dangerous and potentially life-threatening blood clots linked to side effects of Xeljanz, urging doctors and patients to be aware of the risk and seek immediate medical attention if problems develop.
The product liability lawyers at Saiontz & Kirk, P.A. have been reviewing Xeljanx blood clot lawsuits against Pfizer for several months, after the interim results of an ongoing study were released earlier this year, suggesting that certain users may face an increased risk of:
- Pulmonary Embolism
- Deep Vein Thrombosis
- Ischemic Stroke
- Sudden Death
To determine whether you or a loved one may be entitled to financial compensation due to the drug makers failure to previously warn about the blood clot risk with Xeljanz and Xeljanz XR, request a free consultation and case evaluation.
Xeljanz Blood Clot Warnings
In a safety alert issued today, the FDA indicates that the strongest label warning possible will now be added to Xeljanz and Xeljanz XR, which both contain the active pharmaceutical ingredient tofacitinib.
The drug is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and moderate to severe ulcerative colitis, which often involves a twice daily 10mg dose that may pose a particular increased risk of users experiencing blood clot side effects.
Individuals taking Xeljanz should not stop taking the drug without first talking to their doctor. However, the new warnings now provide critical information that users should stop taking Xeljanz and seek immediate medical attention if they experience any unusual symptoms, including those that may be signs of a blood clot, including:
- Shortness of breath
- Chest pain or back pain
- Coughing up blood
- Swelling of a leg or arm
- Bluish or clammy skin
- Leg pain or tenderness, or red/discolored skin
When the FDA first approved Xeljanz in 2012, Pfizer was required to conduct a post-marketing clinical trial to evaluate the heart risks, cancer risks and infection risks. The trial involved evaluation of the 5mg twice daily dose, which is currently approved for rheumatoid arthritis, and a higher 10mg twice daily dose, which is often used for ulcerative colitis and may be prescribed by some doctors.
Pfizer knew or should have known about the blood clot risk highlighted in this study much earlier, and failed to adequately research the potential Xeljanz side effects before the drug was ever introduced or approved.
If earlier warnings had been provided to users and the medical community about the importance of monitoring for signs or symptoms of a blood clot, many individuals may have avoided a pulmonary embolism, deep vein thrombosis, stroke or wrongful death.
To determine whether you or a loved one may be entitled to a Xeljanz settlement, request a free consultation and case evaluation.