EMA takes measures to reduce the risk of severe side effects with JAK inhibitors.
The Committee for Medicinal Products for Human Use (CHMP) in Europe has endorsed the recommendations made by Pharmacovigilance Risk Assessment Committee (PRAC) to reduce the risk of side effects with Janus kinase (JAK) inhibitors which are used for treating various inflammatory disorders.
JAK inhibitors are only recommended in patients mentioned below only if no suitable treatments are available
Adults 65 years and older who are at risk of cardiovascular events
Patients who smoke or had a habit in the past for a long time
Patients with a risk of cancer
CHMP recommended the use of JAK inhibitors with caution in patients at risk of blood clots in the lungs and deep veins. The recommended dose should be reduced in patients at risk of VTE, cancer, or significant cardiovascular problems.
The recommendation was based on the clinical trial of Xeljanz and the initial findings of the observational study from Olumiant. Xeljanz increased the risk of major cardiovascular problems, cancer, VTE, severe infections, and death versus TNF-alpha inhibitors. Further, EMA confirmed that the serious adverse events apply to the other JAK inhibitors.
Xeljanz, Cibinqo, Olumiant, Rinvoq, and Jyseleca are approved for treating various chronic immunology diseases.
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