EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns
Three months after Pfizer flagged blood clot issues and a higher rate of deaths for rheumatoid arthritis patients taking the 10 mg dose of Xeljanz (tofacitinib) in a post-marketing safety study, the EMA has handed down official restrictions in its use.
The agency’s safety committee — pharmacovigilance risk assessment committee, or PRAC — is still in the process of reviewing the evidence, but it is alarmed enough to ban prescription of the 10 mg twice daily regimen in any patients with a high risk of blood clots in the lungs. Those who have heart failure, cancer, a history or predisposition to blood clots are on the list, as are patients taking hormone-based therapies or preparing/recovering from major surgery.
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