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 arthritis and ulcerative colitis medicine, Xeijanz, Xeijanz XR (Tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required a safety trial, which also investigated other potential risks including blood clots in the lungs and death.
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 the treatment of Rheumatoid Arthritis and Psoriatic Arthritis in Adults who do not respond well to Methotrexate. Tofacitnib is also used to treat Ulcerative Colitis, a Chronic Inflammatory disease affecting the Colon.
The agency reportedly advised patients to stop taking tofacitinib without first consulting with their health care professionals, as doing so may worsen the condition.
The agency encouraged healthcare providers and patients to report adverse events or quality problems experienced with the use of this product to the nearest NAFDAC office.