OTTAWA, Ontario, Canada — Health Canada, the governmental public health agency in Canada, announced a warning about the potential for Xeljanz/Xeljanz XR to cause thrombosis. Health Canada said that the agency is working closely with Pfizer Canada ULC with a plan to update the documentation that accompanies the drugs as well as issue a warning to doctors and patients who use Xeljanz or Xeljanz XR about the agency’s concerns. The concerns stem from several post-market trials which suggest that taking either of these drugs on a long-term basis could result in thrombosis, or blood clots, which could result in severe illness or death if left untreated.
The Xeljanz line of medications was designed by Pfizer to help treat rheumatoid arthritis, psoriatic arthritis, as well as ulcerative colitis. Pfizer studied Xeljanz, also known by its generic name Tofacitinib, in a large sample of patients who take Xeljanz for any of the indicated health problems.
The study’s results indicated that the Xeljanz line of medications could have severe and potentially life-threatening side effects. Primarily, the results of the study showed that patients who take Xeljanz to treat rheumatoid arthritis who also suffer from at least one cardiovascular condition are at an elevated risk of developing thrombosis as either a pulmonary embolism, deep vein thrombosis, along with arterial thrombosis should not receive a double dose of Xeljanz because of the significant risk of blood clots.
Health Canada evaluated the result of the research and arrived at certain conclusions. Health Canada determined that patients who could be at risk for developing blood clots should not use Xeljanz. Additionally, Health Canada indicated that doctors must prescribe Xeljanz at the lowest dose indicated, as well as the shortest course indicated for the medication, to patients who have ulcerative colitis. Finally, Health Canada concluded that doctors must closely watch their patients for signs of blood clots, including deep vein thrombosis, pulmonary embolism, along with arterial thrombosis.
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