Xeljanz, an arthritis drug that has been the subject of multiple Health Canada advisories due to its potential to expose users to serious health risks (including heart attack, cancer, and death), has now been approved for use to treat a new type of chronic health condition: ankylosing spondylitis.
Xeljanz is an arthritis drug prescribed for some common chronic pain conditions
Xeljanz was initially approved in 2014 to reduce symptoms associated with rheumatoid arthritis (RA), an autoimmune disease where the body’s immune system attacks the lining of the joints. RA is one of the most common forms of arthritis and harms one in every hundred people in Canada.1
Xeljanz was subsequently approved to treat ulcerative colitis – a type of chronic inflammatory bowel disease, which impact nearly 260,000 Canadians2 – and psoriatic arthritis – a form of inflammatory arthritis that accompanies psoriasis and impacts approximately 0.25% of people.3
For the first several years that the drug was available in Canada, the product monograph contained no warnings or precautions regarding any risk of heart attack, stroke, or blood clots.
Health Canada has concluded Xeljanz poses risks of blood clots, heart attack, cancer
Beginning in early 2019, Health Canada issued a series of safety announcements about Xeljanz concerning clinical trial results that had linked the drug to potentially life-threatening side effects.
Health Canada subsequently published Summary Safety Review decisions, concluding in June 2020 that there was link between Xeljanz and the risk of blood clots and concluding in January 2022 that there was a risk of serious heart-related problems and cancer linked to the use of the medication. Subsequent to its findings, Health Canada required that the manufacturer update the Serious Warnings and Precautions for Xeljanz to assure patients were alerted of the risks.
Despite the risks, Xeljanz has been approved to treat ankylosing spondylitis
Recently, even with the drug having had “black box warnings” added for Thrombosis and Major Cardiovascular Events, Xeljanz received approval for a new indication for use.
In May 2023, Xeljanz was approved to treat ankylosing spondylitis – a type of inflammatory arthritis that impacts the spine and sacroiliac joints and affects as many as one percent of Canadian adults.4 Now, with the new approved indication, some of the approximately 300,000 Canadians with ankylosing spondylitis may become exposed to the risks associated with Xeljanz.
Xeljanz and Xeljanz XR (tofacitinib) class action
Siskinds LLP is seeking to recover compensation for Canadians who suffered injuries resulting from their use of prescription Xeljanz. If you or someone you know used Xeljanz and suffered a heart attack, stroke, thrombosis, and/or cancer, email xeljanz@siskinds.com, call 1-800-461-6166, or visit siskinds.com/xeljanz and complete the form at the bottom of the page.
1 https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/rheumatoid-arthritis
2 https://www.canada.ca/en/public-health/services/chronic-diseases/inflammatory-bowel-disease.html
3 https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis
4 https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/ankylosing-spondylitis