• Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision


EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots

On 14 November EMA 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 recommended 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 recommended 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 a study that was ongoing (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 issued by the EMA’s safety committee (PRAC) were endorsed by the Agency’s human medicines committee (CHMP). They replace the temporary measures put in place at the start of the review in May 2019. The European Commission issued its decision approving these changes on 31 January 2020. 

Key facts

About this medicine
Approved name
International non-proprietary name (INN) or common name
Associated names
About this procedure
Current status
European Commission final decision
Reference number
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Authorisation model
Centrally authorised product(s)
Decision making model
Key dates and outcomes
Procedure start date
PRAC recommendation date
CHMP opinion/CMDh position date
EC decision date
Risk minimisation measures

All documents

Procedure started

Under evaluation

  • List item

    Xeljanz-H-A-20-1485 : EPAR - Scientific conclusions - Article-20 (PDF/29.44 KB)


    First published: 21/08/2019

  • List item

    Xeljanz Article-20 procedure - Annex I, II and III (PDF/521.23 KB)

    First published: 05/07/2019

  • List item

    Xeljanz Article-20 procedure - PRAC assessment report on provisional measures (PDF/84.79 KB)

    First published: 05/07/2019

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Opinion provided by Committee for Medicinal Products for Human Use

    European Commission final decision

  • List item

    Xeljanz Article-20 procedure - EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots (PDF/131.71 KB)

    First published: 06/03/2020

  • List item

    Xeljanz Article-20 procedure - Annex I, II and III

    First published: 06/03/2020

  • List item

    Xeljanz Article-20 procedure - Annex IV (PASS) (PDF/51.82 KB)

    First published: 06/03/2020

  • List item

    Xeljanz-H-A-20-1485-C-4214-0017: Assessment report - Article 20 (PDF/793.92 KB)


    First published: 06/03/2020

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.


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