The JAK inhibitors drug class safety issue has landed in Europe, as indicated by this European Medicines Agency (EMA) February 11, 2022, news item, “EMA starts safety review of Janus kinase inhibitors for inflammatory disorders”. This Xeljanz, Rinvoq, and Olumiant safety review by the EMA follows a December 2021 JAK inhibitors drug class safety FDA action in the US, with Xeljanz, Rinvoq, and Olumiant getting revised drug labels adding more side effects warnings and more drug use restrictions.
Consistent with the December 2021 JAK inhibitors label changes mandated by the FDA here in the US, this February 2022 EMA Xeljanz, Rinvoq, and Olumiant safety review focuses on these JAK inhibitors as treatments for inflammatory disorders.
From the above-referenced EMA news item:
The review was prompted by the final results from a clinical trial (study A3921133) of the JAK inhibitor Xeljanz (tofacitinib). The results showed that patients taking Xeljanz for rheumatoid arthritis and who were at risk of heart disease were more likely to experience a major cardiovascular problem (such as heart attack, stroke or death due to cardiovascular disease) and had a higher risk of developing cancer than those treated with medicines belonging to the class of TNF-alpha inhibitors….
In addition, preliminary findings from an observational study involving another JAK inhibitor, Olumiant (baricitinib), also suggest an increased risk of major cardiovascular problems and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors.
Our law firm is investigating possible drug injury lawsuits involving Xeljanz, Rinvoq, and Olumiant for patients who have suffered serious side effects or adverse drug reactions. Feel free to contact us if you or someone you know might have a Xeljanz, Rinvoq, or Olumiant drug injury case.
And, of course, we will continue to watch for future developments related to JAK inhibitors drug class safety and JAK inhibitors label changes.[Read article in full at original source]
Xeljanz | Rinvoq | Olumiant
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