Pfizer's Xeljanz Under Health Canada's Scrutiny For Safety Risks

  • Canada’s health regulator was launching a probe into Pfizer Inc’s PFE arthritis drug, Xeljanz and Xeljanz XR (tofacitinib), after a trial by the company identified an 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.
  • Xeljanz reported $2.44 billion in worldwide sales and is approved in Canada for 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 an increased risk of blood clots in the lungs and death.
  • Xeljanz’s current Canadian label includes warnings and precautions for cancer and information on heart attacks.
  • Price Action: PFE shares are down 0.03% at $36.04 in the premarket trading on the last check Wednesday.
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