Hemlibra (emicizumab) is used to prevent or reduce the frequency of bleeding episodes in hemophilia A patients. Hemlibra was initially approved by the FDA in 2017. In November 2019, however, some drug safety issues involving Hemlibra were pointed out.
From this letter-to-the-editor piece, “Deaths Associated with Emicizumab in Patients with Hemophilia A”, published in the New England Journal of Medicine (NEJM) November 7, 2019 edition (subscription required), we get the following:
Since the licensing of [Hemlibra (emicizumab)] in such patients, deaths have been reported in 2 patients without inhibitors who had factor VIII deficiency. The circumstances surrounding these deaths have not been made clear. Thus, 13 deaths (including in 11 patients with inhibitors) have now been reported since the original clinical trial was performed. In addition to deaths, thrombotic events and episodes of thrombotic microangiopathic hemolytic anemia have been noted in such patients…. I am concerned that we may be seeing the beginning of a serious public health issue…. More information is needed about adverse events associated with the use of [Hemlibra (emicizumab)]. [footnotes omitted]
We will continue to monitor the various drug safety issues involving Hemlibra.
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