Xeljanz with active ingredient of Tofacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis-pcJIA). It helps to decrease pain/tenderness/swelling in the joints. Tofacitinib is also used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain.
During the past few years, there have been some Xeljanz drug safety alerts issued by the FDA based on a post-marketing safety clinical trial ordered by the FDA when it first approved Xeljanz.
In early February 2021 the FDA doubled-down on these two Xeljanz safety issues: (1) Xeljanz causing heart problems; and (2) Xeljanz causing cancer.
The U.S. FDA is alerting the public that preliminary results from a safety clinical trial show 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.
Pfizer, via a press release, announced the co-primary endpoint results of the completed study in January. Those endpoints — noninferiority with [Xeljanz (tofacitinib)] compared with TNF inhibitors related to major adverse cardiovascular events and malignancies excluding non-melanoma skin cancer — were not met, the company said. In addition, based on the prespecified secondary comparisons, there was no evidence of a difference in the primary endpoints between the two [Xeljanz (tofacitinib)] treatment groups.
According to the Pfizer release, the primary analyses included 135 participants with major adverse cardiovascular events and 164 subjects with malignancies. For [Xeljanz (tofacitinib)], the most frequently reported cardiac event was myocardial infarction, while the most frequently reported malignancy was lung cancer.
This FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)“,
Other safety communications on Xeljanz:
- FDA Drug Safety Communication: “Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate”
- EMA Puts Temporary Restrictions on Tofacitinib Due to PE Risk
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), “Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing“.
- FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)
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