medwireNews: The EMA’s Committee for Medicinal Products for Human Use has announced measures to reduce the risk for serious adverse events associated with Janus kinase (JAK) inhibitors in patients with immunoinflammatory diseases.
For certain high-risk groups, the agency says that these medicines should only be used “if no suitable treatment alternatives are available.” These groups include people aged 65 years and older and those with risk factors for cardiovascular disease, cancer, and venous thromboembolism. If it is necessary to use JAK inhibitors in these patients, the agency recommends that doses should be reduced if possible.
These recommendations are based on a data review, comprising findings from the ORAL Surveillance trial, preliminary results from an observational study of baricitinib, and expert advice from a multidisciplinary group.
The EMA’s advice follows an announcement from the US FDA, which stated that the labels for all currently approved JAK inhibitors must include boxed warnings with information on the risks, and that use of these agents is only permitted in patients with an inadequate response or intolerance to tumor necrosis factor inhibitors.
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