Health Canada is conducting a safety review after issues were discovered during a clinical trial involving rheumatoid arthritis patients being treated with the drug tofacitinib.
Tofacitinib, sold in Canada under the brand names Xeljanz and Xeljanz XR, was found to increase the risk of blood clots in the lungs and even death when the drug was taken at high dosages, which Health Canada said was 10 mg twice a day for the trial.
The patients in the medical trial are now transitioning to the authorized dose of 5 mg twice a day.
The trial, run by Pfizer, was designed to further evaluate the safety of the drug at two dosages and to specifically to assess the risk of cardiovascular events, cancer and opportunistic infections in rheumatoid arthritis patients.
“Health Canada is working with Pfizer to evaluate the available safety information for tofacitinib and will inform the public of any new safety findings as needed, once the review is complete,” said Health Canada.
If you are a patient taking tofacitinib, Health Canada says do not stop or change your dose of tofacitinib without first talking to your health care professional.
You should seek medical attention immediately if you experience symptoms of a blood clot in your lungs, such as sudden unexplained chest pain or shortness of breath, coughing up blood, excessive sweating, clammy or bluish coloured skin, or any other unusual symptoms.
