Ohio Drug Defect Lawyer reviews the FDA warnings on Xeljanz risk for RA and
ulcerative colitis patients. Xeljanz use may increase the risk of pulmonary embolism in certain patients
The US Food and Drug Administration (FDA) has newly added a warning to tofacitinib (Xeljanz and Xeljanz XR) stating an increased risk for pulmonary embolism, and possible and death. The FDA warns that patients taking a 10-mg twice-daily dose of Xeljanz, recommended for patients with ulcerative colitis, could present an added blood clot risk.
Also, the FDA has limited the use of Xeljanz for ulcerative colitis to only patients who are treated inadequately or experience severe adverse effects with alternative drugs. The Xeljanz risk warnings follow a review of data from a post-marketing safety study of tofacitinib (Xeljanz) in patients with rheumatoid arthritis. Higher doses of the drug presented an added risk of pulmonary embolism. The safety study found an increased occurrence of blood clots when patients are treated with 10 mg twice daily compared with patients treated with 5 mg twice daily. The 10-mg dose of tofacitinib is not approved for rheumatoid arthritis or psoriatic arthritis, only approved for ulcerative colitis.
The FDA stated in the recent warning: “While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis.” The FDA first warned about the Xeljanz risk in February 2019.
Joe Lyon is a highly-rated Ohio drug injury lawyer and product liability attorney representing plaintiffs nationwide in a wide variety of claims against pharmaceutical companies.
Tofacitinib (Xeljanz) works by decreasing the activity of a patient’s immune system. It was first approved to treat adult RA patients who did not respond well to methotrexate. In 2017, the FDA approved the medicine to treat patients with psoriatic arthritis who did not respond well to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). In 2018, the FDA approved tofacitinib to treat ulcerative colitis, a chronic, inflammatory bowel disease.
During the most recent safety trial, researchers found an increased occurrence of blood clots in the lungs when patients are treated with tofacitinib 10 mg twice daily. The study results identified 19 cases of Pulmonary Embolism and 45 deaths.
The FDA recommends the following actions:
Patients should not stop or change their own dosage of Xeljanz without talking to their health care professional. Patients, however, should seek medical attention if they experience symptoms of a blood clot in the lungs, such as:
If you or a loved one has suffered a blood clot or pulmonary embolism due to Xeljanz complications, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding the Xeljanz risk of blood clots and pulmonary embolism.