Direct Healthcare Professional Communication (DHPC) on ▼Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF— alpha inhibitors
2021.03.25
Active substance: tofacitinib
Pfizer in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that preliminary data from a completed clinical trial in rheumatoid arthritis patients suggest a higher risk of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer (NMSC)) with tofacitinib as compared to patients treated with a TNF-alpha inhibitor. The benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine should be considered.
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