Comparison of thrombotic adverse events in patients treated with factor VIII products and emicizumab using the 2018-2022 US Food and Drug Administration Adverse Event Reporting System data: comment from Berkowitz et al.

We read with interest the recently published report "Comparison of thrombotic adverse events in patients treated with factor VIII products and emicizumab using the 2018-2022 US Food and Drug Administration Adverse Event Reporting System data" by Cho et al. [1]. However, we have significant concerns about the authors' methodologic approach using pharmacovigilance data, specifically the failure to critically analyze and account for reporting biases.