OTTAWA, March 15, 2019 /CNW/ - Health Canada is conducting a safety review after issues were discovered during a clinicaltrial involving rheumatoid arthritis patients being treated with the drug tofacitinib (sold in Canada under the brand names Xeljanz and Xeljanz XR).
Tofacitinib is a prescription drug used to treat adults with
The ongoing clinical trial, run by Pfizer, found an increased risk of blood clots in the lungs and of death when the drug was taken at a high dose of 10 mg, twice a day. Patients who were taking 10 mg of tofacitinib twice a day are now transitioning to the lower, currently authorized dose of 5 mg twice a day.
The purpose of this clinical trial is to further evaluate the safety of tofacitinib at two doses (5 mg twice a day and 10 mg twice a day) when taken with another drug (methotrexate). The trial is designed specifically to assess the risk of cardiovascular events, cancer and opportunistic infections in rheumatoid arthritis patients.
Pfizer is conducting the trial in multiple countries, including Canada. The trial involves patients who are at least 50 years of age and have at least one cardiovascular risk factor.
Pfizer is conducting other clinical trials in Canada that involve tofacitinib at 10 mg twice a day. Health Canada has requested the postponement of recruitment in a pediatric trial using this dose, and has asked investigators of other trials to inform participants and to secure their agreement to continue in the study. Health Canada is working with Pfizer to monitor the situation closely and continues to assess these clinical trials.
Health Canada has not authorized the high dose of 10 mg twice a day for rheumatoid arthritis or psoriatic arthritis; this dose is authorized only for patients with ulcerative colitis in people who do not respond well to other medications. For patients with ulcerative colitis, the Canadian prescribing information recommends that patients use the lowest effective dose possible for maintenance therapy, to lower the risk of adverse reactions.
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.
What you should doIf you are a patient taking tofacitinib:
If you are a health care professional:
Report health or safety concernsTo report a side effect to a health product to Health Canada:
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SOURCE Health Canada
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