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(Last Updated On: March 4, 2021)

Xeijanz, Xeijanz XR (tofacitinib): Initial Safety Trial Results Find Increased Risk of Serious Heart related Problems and Cancer with Arthritis and Ulcerative Colitis Medicines

March 4, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration about an increased risk of serious heart-related problems and cancer in relation to the use of the arthritis and ulcerative colitis medicine Xeijanz, Xeijanz XR (Tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final result are not yet available.

Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to Rheumatoid Arthritis and Psoriatic Arthritis, and ulcerative colitis. It is used for treatment of Rheumatoid Arthritis and Psoriatic Arthritis in Adults who do not respond well to Methotrexate. Tofacitnib is also used to treat Ulcerative Colitis, Chronic Inflammatory disease affecting the Colon.

Healthcare providers’ and Patients’ Action

Patients should not stop taking tofacitinib without first consulting with their health care professionals, as doing so may worsen the condition.

Healthcare providers and patients are encouraged to report adverse events or quality problems experienced with the use of this product to the nearest NAFDAC office,

NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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