Use of Xeljanz (tofacitinib) restricted while European Medicines Agency (EMA) review regarding the risk of pulmonary embolism is ongoing

17 May 2019
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Use of Xeljanz (tofacitinib) restricted while European Medicines Agency (EMA) review regarding the risk of pulmonary embolism is ongoing

The HPRA would like to inform you that the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) have initiated a review (Article 20 Referral) of Xeljanz (tofacitinib) following evaluation of data from an ongoing clinical trial in which an increased risk of pulmonary embolism (PE) and overall mortality was observed in patients using the tofacitinib 10mg twice daily dose.

As a temporary measure while the review is ongoing PRAC has recommended a contraindication to the use of the 10mg twice daily dose of Xeljanz (tofacitinib) in patients at high risk of PE.

Please find attached the EMA's communication published on their website today with a link below to the announcement. A Direct Health Care Professional Communication (DHPC) will follow this announcement:

Email: library@icgp.ie, Tel: 01 6763705, Fax: 01 6765850
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