FDA - Annual Fatalities Report FY2011

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

"In combined Fiscal Years 2007 through 2011, Transfusion Related Acute Lung Injury (TRALI) caused the highest number of reported fatalities (43%), followed by hemolytic transfusion reactions (total of 23%) due to non-ABO (13%) and ABO (10%) incompatibilities. Complications of Transfusion Associated Circulatory Overload (TACO), microbial infection, and anaphylactic reactions each accounted for a smaller number of reported fatalities (Table 1 and Figure 1). Over the last three fiscal years, the number of fatal TACO reports has decreased, from 12 (27%) in FY2009, to 8 (20%) in FY2010, and 4 (13%) in FY2011. Recent articles provide additional information about TACO. 5,6,7  The number of reported transfusion related deaths attributable to anaphylaxis8,9 has remained small over the last five fiscal years; with the exception of one FY2010 case, in which IgA levels were not measured, patient IgA deficiency was ruled out in 11 of the 12 cumulatively reported cases. In another FY2010 case, a haptoglobin deficiency was possibly implicated in the patient's anaphylactic reaction."

For the complete report please see "Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2011".