There appears to be a new Xeljanz drug-safety problem for patients with ulcerative colitis (UC) who use the 10 mg twice daily recommended dosage of Xeljanz.
In a February 20, 2019 Endpoints News article written by John Carroll, “Pfizer drops 10 mg dose of best-selling Xeljanz as study spotlights cardio safety issue, higher rate of deaths”:
One of Pfizer’s top up-and-coming revenue producers has run into a serious safety issue during a post-marketing study.
According to the company, rheumatoid arthritis patients taking a 10 mg dose of Xeljanz (tofacitinib) in an ongoing safety study are being moved to a 5 mg dose after the independent monitoring board determined that there was an imbalance in the rate of death between the 10 mg drug arm (twice daily) and both their 5 mg arm and a group taking a TNF inhibitor in the control group. The monitors also outlined evidence the 10 mg dose group experienced “a statistically and clinically important difference in the occurrence of pulmonary embolism.”
We give Endpoints News and John Carroll a well-deserved “hat-tip” for breaking this emerging Xeljanz drug-safety story.
Be assured that we will continue to follow their coverage of this Xeljanz drug-safety issue as well as watch for possible FDA regulatory action concerning the Xeljanz 10 mg twice-daily dose recommended for ulcerative colitis patients.
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