23.03.2020 - Conclusion of the procedure

With the publication of the European Commission's decision of 31 January 2020, the sending of the Dear Doctor Letter (Rote-Hand-Brief) and the publication of the educational material on 20.03.2020, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 on Xeljanz® has been completed.

15.11.2019 - CHMP opinion

The Committee for Medicinal Products for Human Use (CHMP) of the EMA confirms the assessment of the Committee for Pharmacovigilance Risk Assessment (PRAC) that the use of Xeljanz® (tofacitinib) could further increase the risk of blood clots forming in the lungs and deep veins in patients who are already at high risk.

05.11.2020 - PRAC recommendation

A review of the drug Xeljanz® (tofacitinib) by the Committee for Pharmacovigilance Risk Assessment (PRAC) at the European Medicines Agency (EMA) revealed, that Xeljanz® could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk.

17.05.2019 - Procedure started

The risk assessment procedure according to Art. 20 of Regulation (EC) No. 726/2004 on Xeljanz (tofacitinib) was initiated by the European Commission. The EMA Safety Committee (PRAC) recommends that doctors should not prescribe the 10 mg dose of xeljanz (tofacitinib) administered twice daily to patients at high risk of blood clots in the lungs.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Xeljanz

To the risk assessment procedure (available in German only)