EMA has concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk.

As a result, the Agency is recommending that Xeljanz should be used with caution in all patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk of blood clots unless there is no suitable alternative treatment. Further, EMA is recommending that, due to an increased risk of infections, patients older than 65 years of age should be treated with Xeljanz only when there is no alternative treatment.

These recommendations follow the Agency’s review of an ongoing study (study A3921133) in patients with rheumatoid arthritis and an increased risk of cardiovascular disease, plus data from earlier studies and consultation with experts in the field. All data combined showed that the risk of blood clots in deep veins and lungs was higher in patients taking Xeljanz, especially the 10 mg twice daily dose, and in those being treated for an extended period. Results also showed a further increased risk of serious and fatal infections in patients older than 65 years of age.

The recommendations were issued by the EMA’s safety committee (PRAC) and have now been endorsed by the Agency’s human medicines committee (CHMP). They will replace the measures put in place at the start of the review in May 2019. The changes come into force when the European Commission issues its decision.ç

Posted on the EMA website on 15 November 2019