Arthritis Drug linked to Heart-Related Problems and Cancer by FDA
The US Food and Drug Administration has issued a warning against the use of tofacitinib, sold under the brand name Xeljanz and Xeljanz XR. The regulatory agency has alerted an increased risk of serious heart-related problems and cancer risk with the use of Janus kinase inhibitor, tofacitinib. The FDA has issued this safety alert to patients and health providers based on the interim analysis from a safety clinical trial comparing tofacitinib and tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA).
TOFACITINIB Regulatory journey:
• In 2012, the FDA approved tofacitinib to treat adults with RA who did not respond well to the medicine methotrexate.
• In 2017, It was approved to treat patients with a second condition that causes joint pain and swelling, psoriatic arthritis (PsA), who did not respond well to methotrexate or other similar medicines.
• In 2018, it was approved for the treatment of ulcerative colitis.
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