EMA Reviewing Cardiovascular & Cancer Risk From Five Janus Kinase Inhibitors
Executive Summary
The European Medicines Agency has been asked to make a recommendation by 30 September on whether the marketing authorization for the products concerned should be maintained, varied, suspended or revoked.
You may also be interested in...
EMA Recommends New Measures For JAK Inhibitors After Confirming Serious Risks
The sponsors of five EU-approved Janus kinase inhibitors for inflammatory conditions will have to update their product information to reflect new measures and warnings from the European Medicines Agency.
US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks
Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.
EU: Pfizer Warns Doctors About Blood Clot Risk With Xeljanz
Now that the European Medicines Agency has finalized its formal safety review procedure into Xeljanz, Pfizer is telling health care professionals what precautions they must take when prescribing the drug.