Risk of major adverse cardiovascular events and malignancies (excluding non-melanoma skin cancer) with use of Xeljanz (tofacitinib) relative to tumour necrosis factor inhibitors

A Dear Healthcare Professional Letter has been issued by Pfizer to inform healthcare professionals of preliminary results from a safety clinical trial which found an increased risk of major adverse cardiovascular events and malignancies (excluding non-melanoma skin cancer) with Xeljanz, compared with tumor necrosis factor inhibitors. Pfizer is working with regulatory agencies to review the full results and analyses as they become available. In addition, Pfizer is conducting additional analyses to further identify any risk factors that might have contributed to the increased risk, which will inform the need for any additional risk mitigation measures. Healthcare professionals are advised to consider the benefits and risks of Xeljanz when deciding whether to prescribe or continue patients on the medicine and to continue to follow the recommendations in the Xeljanz prescribing information. Healthcare professionals are also recommended to counsel their patients about the risks and benefits of Xeljanz and to advise them not to stop taking Xeljanz without consulting their healthcare professional. Please refer to the letter for details. Published: 29 Mar 2021

Dear Healthcare Professional Letters