FDA Warns Increased Risk of Serious Heart-Related Injury for Xeljanz Users

FDA Warns Increased Risk of Serious Heart-Related Injury for Xeljanz Users

In a September 16th update to previous findings from 2019 and early 2021, the US Food and Drug Administration (FDA) has concluded that there is an increased risk of serious heart-related health effects such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz, Xeljanz XR, and other products within the same drug class. 

These safety trial findings have led the FDA to require new and updated warnings for medications similar to Xeljanz. The arthritis medications mentioned in this update, Olumiant and Rinvoq, have not undergone safety trials like Xeljanz, but since they share largely the same mechanisms, warnings are required and extreme caution should be afforded. 

The FDA is requiring revisions to boxed warnings on these products to include language about the health related risks these products pose. Healthcare professionals are recommended to carefully consider a patient’s health history before suggesting Xeljanz or related medications. 

The FDA has also provided guidance as to what patients are approved to use these medications. These products should be reserved for patients who cannot tolerate one or more TNF blocker. TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases, such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. 

Xeljanz, Olumiant, and Rinvoq are part of a drug class called Janus kinase (JAK) inhibitors. These medicines work to suppress the immune system and treat certain serious, chronic, and progressive inflammatory conditions. All three medicines are approved to be used alone or with other medicines to treat rheumatoid arthritis. Xeljanz is also approved to treat psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.

​​“FDA Approves Boxed Warning about Increased Risk of Blood Clots and Death with Higher Dose of Arthritis and Ulcerative Colitis Medicine Tofacitinib (Xeljanz, Xeljanz XR).” U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 26 July 2019, https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and#:~:text=Safety%20Announcement,in%20patients%20with%20ulcerative%20colitis.

Information on Tumor Necrosis Factor (TNF) Blockers.” U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 25 Feb. 2021, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-tumor-necrosis-factor-tnf-blockers-marketed-remicade-enbrel-humira-cimzia-and-simponi.

Safety Trial Finds Risk of Blood Clots in the Lungs.” U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 25 Feb. 2021, https://www.fda.gov/drugs/drug-safety-and-availability/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr.

Serious Heart Events, Cancer, Blood Clots for Certain Jak Inhibitors.” U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 16 Sept. 2021, https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death. 

 

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Litigation Updates

FDA Warns Increased Risk of Serious Heart-Related Injury for Xeljanz Users

October 13, 2021

October 13, 2021

FDA Warns Increased Risk of Serious Heart-Related Injury for Xeljanz Users

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