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FDA Warns of New Dangers Associated with JAK Inhibitors

The Food and Drug Administration (FDA) has published new warnings about several medications for the treatment of arthritis and other inflammatory conditions. These medications, known as Janus kinase (JAK) inhibitors, are used to suppress an over-reactive immune system to reduce joint pain and swelling and prevent long term damage to joints. JAK inhibitors belong to a class of medications known as DMARDs, or disease-modifying antirheumatic drugs. The FDA granted approval to three medications for the treatment of rheumatoid arthritis: baricitinib (Olumiant), tofacitinib (Xeljanz) and upadacitinib (Rinvoq).

New Warnings Following Results of Safety Clinical Trial for Xeljanz and Xeljanz XR

LK previously alerted readers to warnings issued by the FDA concerning Xeljanz and Xeljanz XR (tofacitinib), which are used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. In February, 2019, the FDA reported that there is an increased risk of blood clots and death in patients who are taking Xeljanz for the treatment of rheumatoid arthritis. The FDA then issued another alert in February, 2021 to inform patients that preliminary results of a clinical trial indicated that serious heart conditions and cancer are associated with the use of Xeljanz.

Now the FDA has published the results of a large randomized safety clinical trial and concluded that Xeljanz and Xeljanz XR pose an increased risk of serious cardiovascular conditions. This may include heart attack, stroke, cancer, blood clots, and death. In its clinical trial, the FDA reviewed the side effects and complications of Xeljanz and Xeljanz XR as compared to another medication for the treatment of rheumatoid arthritis known as tumor necrosis factor (TNF) blockers. In addition, lower doses of Xeljanz were linked to an increased risks of blood clots and death contrary to previous results showing that serious conditions and death were associated only with higher doses of the medication.

Updated Warnings Also Required for Two Other JAK Inhibitor Drugs

The FDA also notified the public about updated warnings for two other JAK inhibitors that belong to the same class of drugs as Xeljanz. These medications- Olumiant and Rinvoq- may present similar health risks as Xeljanz, although they have not been evaluated in large scale clinical trials. Because these JAK inhibitors work in the same way as Xeljanz, patients are warned that they may also have an increased risk of serious cardiovascular conditions. Finally, two other JAK inhibitors- Jakafi and Inrebic- were not included in the FDA warning since they are not used for the treatment of arthritis and other inflammatory diseases.

Contact our lawyers to review whether you or a family member may be entitled to financial compensation as a result of serious health conditions associated with taking JAK inhibitors. Levy Konigsberg LLP is currently accepting cases in all 50 states.

If you or a loved one has suffered complications from Xeljanz or other JAK inhibitors, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with lawyers at our law firm, please call (800) 315-3806 or submit an email inquiry.


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