Canada’s health regulator said on Tuesday it was launching a probe into Pfizer Inc’s arthritis drug, Xeljanz, after a trial by the company identified increased risk of serious heart-related issues and cancer in the participants.
The trial investigated the long-term safety of Xeljanz at two doses in patients with rheumatoid arthritis, who are at least 50 years old and have at least one cardiovascular risk factor, the regulator said.
Xeljanz, which brought in worldwide sales of US$2.44 billion for Pfizer in 2020, is approved in Canada for some patients of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.
Health Canada said it had conducted a safety review of the drug in 2019 after a trial identified increased risk of blood clots in the lungs and death.
Xeljanz’s current Canadian label carries warnings and precautions for cancer and information on heart attacks, the agency said.
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