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The agency is reviewing Xeljanz (tofacitinib) because of the risk of blood clots in the lungs.
The European Medicines Agency (EMA) announced on May 17, 2019 that its Pharmacovigilance Risk Assessment Committee (PRAC) is recommending that doctors not prescribe the 10 mg twice daily dose of Xeljanz (tofacitinib) in patients with ulcerative colitis who have a history of blood clots, clotting disorders, or have had heart failure, cancer, or are taking combined hormonal contraceptives or undergoing hormone replacement therapy. Other potential risk factors should also be taken into consideration before prescribing, says EMA.
The recommendation comes after results of an ongoing study showed an increase risk of blood clots in the lungs with the 10 mg twice daily dose. Preliminary study results showed 19 cases of pulmonary embolism out of 3883 patient-years in those study patients taking tofacitinib 10 mg twice daily compared with three cases out of 3982 in study patients taking a tumor necrosis factor (TNF) inhibitor. The study also reported 45 deaths (from a variety of causes) out of 3897 patient-years in the 10 mg twice daily arm compared with 25 cases out of 3982 patient-years in the TNF inhibitor group. The study is ongoing, and the agency has stated it plans to review all available evidence. Updated guidance will be provided after the conclusion of the review.
Xeljanz was approved in the European Union in 2017 to treat moderate to severe rheumatoid arthritis. The approval was extended in 2018 to the treatment of psoriatic arthritis and sever ulcerative colitis. The 10 mg dose is used for an initial treatment of patients with ulcerative colitis and is higher than the recommended 5 mg twice daily dose for patients with rheumatoid arthritis.