November 2019 NEJM Letter Points Out Possible Public Health Issue For Hemlibra Used By Hemophilia A Patients
We recently learned about drug safety issues involving Hemlibra (emicizumab), which is an injection used to prevent or reduce the frequency of bleeding episodes in hemophilia A patients. In the two years since Hemlibra was initially approved by the FDA in 2017 there have been various Hemlibra adverse events reports, including two patient deaths associated with Hemlibra use.
For some details of emerging public health concerns about Hemlibra used by hemophilia A patients we turn to a Correspondence item by Louis M. Aledort, M.D., of the Icahn School of Medicine at Mount Sinai, in New York, that was published by the New England Journal of Medicine (NEJM). From this letter-to-the-editor piece, "Deaths Associated with Emicizumab in Patients with Hemophilia A", which appeared in the November 7, 2019 edition of the NEJM medical journal (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. Neither of these complications has been reported in patients who had factor VIII deficiency without inhibitors and who were receiving [Hemlibra (emicizumab)]. [footnotes omitted]
To learn more about Hemlibra and which set of hemophiliac patients may benefit from Hemlibra, you can read the Full Prescribing Information document (Revised: 10/2018) from Genentech, the responsible drug company.
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Returning to this November 2019 NEJM letter about Hemlibra, Dr. Aledort concludes with this cautionary statement:
It is understandable that both patients with hemophilia A and their physicians are enthusiastic about the potential advantages of subcutaneous administration of [Hemlibra (emicizumab)]. However, I am concerned that we may be seeing the beginning of a serious public health issue. This population of patients has already been exposed to risks associated with therapy, and we should embrace this very important biologic agent with caution. More information is needed about adverse events associated with the use of [Hemlibra (emicizumab)]. [footnote omitted]
We will continue to monitor the drug safety profile of Hemlibra, and welcome any relevant information you may have by submitting a Comment below or sending me a private email.
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