Thornton Law Firm LLP is actively investigating Xeljanz claims on behalf of patients injured by this potentially defective drug. If you or a loved one has taken Xeljanz or Xeljanz XR and been diagnosed with blood clots, heart problems, cancer, or death, call the Xeljanz lawyers at Thornton Law Firm 888-341-1405 for a free consultation to assess your potential claim.
The U.S. Food and Drug Administration (FDA) has concluded that “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 and Xeljanz XR (tofacitinib).” In a communication dated September 1, 2021, the FDA states that after review of a large randomized safety clinical trial, it will now require revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz and Xeljanz XR to include information about the risks of serious heart-related events, cancer, blood clots, and death. Patients taking Xeljanz who suffered pulmonary embolisms, cardiovascular problems, cancer and death may have a claim for damages against the manufacturer, Pfizer.
What is Xeljanz?
Xeljanz is a Janus kinase (JAK) inhibitor that works inside your cells to disrupt pathways believed to play a role in inflammation. Generic name tofacitinib, Xeljanz was approved by the FDA in 2012 to treat adults with rheumatoid arthritis who did not respond well to the drug methotrexate. Xeljanz is a pill, and is also available in an extended release form (Xeljanz XR) and as an oral solution. In 2017 it was approved for treatment of psoriatric arthritis, and in 2018 the FDA approved it for the treatment of ulcerative colitis.
FDA Warnings About Xeljanz
The FDA has issued four warnings about Xeljanz since 2019. In February of 2019 the FDA alerted the public that the Xeljanz clinical trial found an increased risk of blood clots and death associated with Xeljanz at a 10 mg/2 times per day dose. This dose was not approved for rheumatic arthritis; it was only approved for ulcerative colitis.
In July of 2019 the FDA approved a Black Box warning for tofacitinib’s prescribing information for the 10 mg/2 times a day dose.
In February 0f 2021 the FDA warned providers of an increased risk for serious heart-related issues and cancer among older patients, compared with TNF inhibitors. Unlike the earlier FDA warnings, this warning includes both the 5 mg and 10 mg doses of Xeljanz, thereby including all conditions for which the drug can be prescribed. This is the first time cancer has been associated with Xeljanz.
In September of 2021 the FDA expanded the Xeljanz safety label with another Boxed warning, the FDA’s most prominent warning, of the increased risks of serious heart-related events, cancer, blood clots and death.
What Can You Do?
Patients should not discontinue Xeljanz without first consulting their health professionals, as doing so could worsen their condition according to the FDA. Patients should talk to their health providers about any questions or concerns. Any patient experiencing symptoms should seek medical attention immediately.
If you or a loved one have been diagnosed with blood clots, pulmonary embolisms, heart problems, cancer, or death after taking prescription Xeljanz, you may have a claim for money damages. Contact the Xeljanz lawyers at Thornton Law Firm by calling 1-888-341-1405 or telling us your story here. Thornton Law Firm’s experienced drug and medical device attorneys can help you assess your potential claim. The consultation is free and will be held in complete confidence. Like all legal claims, Xeljanz claims have short, strictly enforced legal time limits. Do not delay seeking legal advice.