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FDA Issues Warnings Regarding Xeljanz (tofacitinib)

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On July 26, the U.S. Food and Drug Administration (FDA) approved new warnings of an increased chance of blood clots and fatalities for ulcerative colitis patients who are taking 10 mg of tofacitinib (Xeljanz or Xelijanz XR) twice a day. The warnings were issued in response to the interim results of an ongoing safety trial.

What is Tofacitinib?

The FDA approved the medication tofacitinib in 2012 to decrease immune system activity in patients with rheumatoid arthritis (RA) who did not react favorably to the medication methotrexate. In 2017, approval for tofacitinib was extended for psoriatic arthritis (PsA) patients who did not respond well to methotrexate or similar medications, and the next year tofacitinib was approved to treat ulcerative colitis, a chronic disease affecting the colon.

In light of the warnings, the approved use of tofacitinib for ulcerative colitis will now be restricted to patients for whom other medications do not provide effective treatment, or those who experience serious side effects. The twice-daily dose of tofacitinib is only approved for ulcerative colitis during the initial treatment phase and for long-term use (in limited situations). Although increased risk for blood clots and death were observed in patients taking 10 mg twice a day for (RA) or (PsA), that particular dosage is not approved for such patients.

Tofacitinib Lawsuits

Lawsuits are being filed alleging injury connected with tofacitinib use. To recover damages in a tofacitinib case, you will need to prove that:

If you think you might have a potential tofacitinib claim, you should take prompt action, as various deadlines and statutes of limitations might apply to the case and could bar you from recovery should you delay bringing the claim.

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