Xeljanz (tofacitinib): Initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF-alpha inhibitors.

Summary: 

• Preliminary data from a completed clinical trial in rheumatoid arthritis patients (A3921133) 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. 
• Keep considering the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine. Continue to follow the recommendations in the tofacitinib product information.
• Advise patients that they should not stop taking tofacitinib without first consulting their healthcare professional and to talk to their healthcare professional if they have questions or concerns.
• Further evaluation of the data from study A3921133 and their potential impact on tofacitinib product information by EMA is currently ongoing and final conclusions and recommendations will be communicated as soon as the evaluation has been completed.