Updates on the number of fatalities in people treated with emicizumab, whether known to be related to emicizumab or not, are and will continue to be included in public safety registries and databases, including EUHASS (European Haemophilia Safety Surveillance), FAERS (FDA Adverse Event Reporting System), and UKHCDO (United Kingdom Haemophilia Centre Doctors' Organisation). We have also worked with experts in the field to develop a series of manuscripts reviewing mortality in haemophilia A and using this to establish a framework to further assess the reported fatalities in people receiving emicizumab.
These manuscripts have been published in the Journal of Thrombosis and Hemostasis in December 2020 and are available on this website under the Manuscripts/Safety section.
In regards to providing case details or causality, we are not able to provide extensive information related to serious adverse events or fatalities reported in the post-approval setting because the level of detail available and Roche's ability to confirm individual details is variable. In addition, the information on adverse events provided to Roche from consumers or physicians after approval is confidential, and detailed information can not be shared without the consent of the reporting person, the patient or patient’s family. Patient privacy is very important to Roche, so we are also careful not to disclose specific details about an adverse event that could jeopardise the privacy of either the patient or their family, or breach patient confidentiality.
We also continue to work with experts in the field to collect, analyse, and publish relevant data and information related to the safety and efficacy of emicizumab. We will share links to these published materials on this website as they become available.