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FDA: initial safety trial results have found increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Tofacitinib


The FDA ( U.S. Food and Drug Administration ) is alerting the public that preliminary results from a safety clinical trial have shown an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz 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 results are not yet available.

FDA will evaluate the clinical trial results and will work with the drug manufacturer to obtain further information as soon as possible.
FDA will communicate the final conclusions and recommendations after completion of the review.

Patients should not stop taking Tofacitinib without first consulting with health care professionals.

Health care professionals should consider the benefits and risks of Tofacitinib when deciding whether to prescribe or continue patients on the medicine.
Continue to follow the recommendations in the Tofacitinib prescribing information.

Tofacitinib was first approved in 2012 to treat adults with rheumatoid arthritis ( RA ) who did not respond well to the medicine Methotrexate. In rheumatoid arthritis, the body attacks its own joints, causing pain, swelling, and loss of function.
In 2017, FDA approved Tofacitinib to treat patients with a second condition that causes joint pain and swelling, psoriatic arthritis, who did not respond well to Methotrexate or other similar medicines.
In 2018, FDA approved the medicine to treat ulcerative colitis, which is a chronic, inflammatory disease affecting the colon.

Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

When FDA first approved Tofacitinib, the regulatory Agency required the manufacturer to conduct a safety clinical trial in patients with rheumatoid arthritis who were taking Methotrexate to evaluate the risk of serious heart-related events, cancer, and infections.
The trial studied two doses of Tofacitinib ( 5 mg twice daily, which is the approved dosage for psoriatic arthritis, and a higher 10 mg twice daily dosage ) in comparison to another type of rheumatoid arthritis medicine called a TNF inhibitor.
Patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor.
In February 2019 and July 2019, FDA warned that interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the Tofacitinib prescribing information.
The clinical trial is now complete and initial results have shown a higher occurrence of serious heart-related events and cancer in patients with rheumatoid arthritis treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor.
FDA is awaiting additional results from the trial. ( Xagena )

Source: FDA, 2021

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