EMA issues safety notice on Xeljanz


  • Dawn O'Shea
  • Univadis Medical News
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The European Medicines Agency (EMA) is advising against the use of Xeljanz (tofacitinib) in patients at risk of thrombosis.

The EMA recommends that the maintenance dose of 10 mg twice daily should not be used in patients with ulcerative colitis who are at a high risk of thrombosis or in those who are aged older than 65 years, unless there is no alternative treatment.

The decision follows an EMA review of evidence from an ongoing study (study A3921133) which concluded that Xeljanz may increase the risk of pulmonary embolism (PE) and deep vein thrombosis (DVT) in at-risk patients. The study of patients with rheumatoid arthritis with increased risk for cardiovascular disease showed an increased risk of DVT and PE with both the 5 mg and 10 mg twice daily doses of Xeljanz compared with patients taking TNF-inhibitors.

The EMA also re-assessed additional data from earlier studies. All data combined showed that the risk of thrombosis was higher in patients taking Xeljanz, especially with the 10 mg twice daily dose and in those being treated for an extended period. The evidence also showed a further increased risk of serious and fatal infections in patients older than 65 years of age.