XELJANZ (tofacitinib): risk of serious adverse cardiovascular events and malignancies (except non-melanoma skin cancer). The European Medicines Agency has published a Direct Healthcare Professional Communication (DHPC)

XELJANZ (tofacitinib): Risk of serious adverse cardiovascular events and malignancies (excluding non-melanoma skin cancer). The European Medicines Agency has published a communication to healthcare professionals (DHPC)

24.03.2021, a Direct Healthcare Professional Communication (DHPC) was published on the official website of the European Medicines Agency, containing important information for healthcare professionals who prescribe, dispense or administer the medicinal product XELJANZ (tofacitinib)

(https://www.ema.europa.eu/en/medicines/dhpc/xeljanz-tofacitinib-initial-clinical-trial-results-increased-risk-major-adverse-cardiovascular).

Following the PRAC meeting on 08-11 March 2021, the marketing authorization holder of the medicinal product XELJANZ (tofacitinib), Pfizer, was recommended to distribute direct healthcare professional communications (DHPC) to inform about the risk of serious adverse cardiovascular events and malignancies (except non-melanoma skin cancer (NMSC)) compared with the use of tumor necrosis factor (alpha) inhibitors.

The appeal states that

• preliminary data from a completed clinical study in patients with rheumatoid arthritis (A3921133) indicate a higher risk of serious adverse cardiovascular events and malignancies (excluding non-melanoma skin cancer (NMSC)) with the use of tofacitinib compared with patients who used tumor necrosis factor (alpha) inhibitors.
• healthcare professionals should continue to take into account the benefits and risks of tofacitinib when deciding on prescribing or continuing treatment for patients. The recommendations given in the instructions for medical use of tofacitinib should also continue to be followed.
• patients should be warned that they must not stop taking tofacitinib without first consulting their treating physician, and should consult him or her if they have any questions or problems with treatment.
• further evaluation of the data from study A3921133 and possible amendments by the EMA to the package insert (instructions for medical use) of tofacitinib are ongoing, and the final conclusions and recommendations will be communicated as soon as the evaluation is completed.

The full text of the communication to health care professionals on the safety of use of the medicinal product XELJANZ (tofacitinib) can be found at the linkhttps://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-xeljanz-tofacitinib-initial-clinical-trial-results_en.pdf