AIFA Agenzia Italiana del Farmaco
EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
EMA’s Committee for Medicinal Products for Human Use (CHMP) has approved measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of serious side effects with inhibitors of Janus kinase (JAK) used to treat several chronic inflammatory disorders.These side effects include cardiovascular conditions, blood clots, cancer and serious infections.
These medicines should only be used in the following patients if suitable treatment alternatives are not available: people aged 65 years and over, people at increased risk of serious cardiovascular problems (such as heart attack or stroke), those who smoke or have smoked for a long time in the past, and those at increased risk of cancer.
JAK inhibitors should be used with caution in patients with risk factors for blood clots in the lungs and deep veins (venous thromboembolism, VTE) other than those listed above. In addition, where possible, doses should be reduced in groups of patients at risk for VTE, cancer or severe cardiovascular problems.
The recommendations follow a review of the available data, including the final results of a clinical trial on the JAK inhibitor (tofacitinib) and preliminary results from an observational study in .The review also included opinions from a panel of expert rheumatologists, dermatologists, gastroenterologists and patient representatives.
The review confirmed that it increases the risk of serious cardiovascular problems, cancer, VTE, serious infections and death from any cause compared to medicines belonging to the class of TNF-alpha inhibitors. EMA has now concluded that these safety findings apply to all approved uses of JAK inhibitors in chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata).
Product information for JAK inhibitors used to treat chronic inflammatory disorders will be updated with new recommendations and warnings. In addition, the educational material for patients and healthcare professionals will be revised accordingly.
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Source — https://www.univadis.it/viewarticle/lema-conferma-le-misure-per-ridurre-al-minimo-il-rischio-di-gravi-effetti-collaterali-con-gli-inibitori-della-janus-chinasi-per-i-disturbi-infiammatori-cronici