Anti-Rh(D) Utilization Prior To and Following The FDA Mandate For Hemoglobinuria Screening 03/11/10

Background Anti-Rh(D) has appeal for use in immune thrombocytopenia (ITP) due its rapid onset of action (24 hours) and short infusion time (10 minutes).  There is reluctance by some physicians to use anti-Rh(D), however, following FDA reports in 2000 of 15 cases of acute hemoglobinemia and/or hemoglobinuria (Gaines Blood 2000) and in 2005 of 6 cases of disseminated intravascular coagulation in association with acute hemoglobinemia and/or hemoglobinuria (Gaines Blood 2005). On 03/11/10, the FDA issued a black box warning stating that patients with ITP treated with WinRho (anti-Rh(D)) should be monitored in a healthcare setting for 8 hours following infusion for symptoms of intravascular hemolysis and for hemoglobinuria. Our institution adopted this 8-hour monitoring practice. Specific Aims To determine if the FDA black box warning has impacted on anti-Rh(D) utilization at St. Luke's-Roosevelt Hospital Center, New York, NY. Methods Institutional Review Board approval was obtained. The charts of consecutive patients with ITP treated with anti-Rh(D) who were followed in a hematology-oncology practice between 01/01/06 and 06/30/13 were reviewed. The ICD-9 code 287.31 for ITP was used to identify inpatients treated with anti-Rh(D) between 01/01/06 and 06/30/13. The number of outpatient and inpatient anti-Rh(D) infusions per annum was computed. Results The annual number of outpatient and inpatient anti-Rh(D) infusions is shown in [Table 1][1]. Infusions occurred predominantly in the outpatient setting. Eight-hour monitoring has been adhered to. While there has been some fluctuation in anti-Rh(D) utilization, there has not been a significant decline. View this table: Table 1 Annual number of outpatient and inpatient anti-Rh(D) infusions Conclusion Despite the FDA requirement for patients to spend increased time at health care centers following anti-Rh(D) infusions, anti-Rh(D) utilization at our institution has not declined. Disclosures: No relevant conflicts of interest to declare. [1]: #T1