Hypersensitivity transfusion reactions to fresh frozen plasma: a retrospective analysis of the French hemovigilance network.

Few data are currently available on hypersensitivity transfusion reactions (HTRs) after exposure to fresh frozen plasma (FFP). Between 2000 and 2018, three different FFP production strategies have been used in France, leading to the concomitant use of different types of FFP. The objective of this study was to describe the rate of FFP-related HTRs and to assess the relative risk of each type of FFP. HTR following FFP transfusion between 2000 and 2018 were retrospectively extracted from the national hemovigilance database of the French National Agency for Medicines and Health Products Safety (ANSM). Temporal evolution of the incidence of reactions was modeled using logistic regression. During the study period, the overall rate of FFP-related HTRs was 52.0 (95% CI 50.2-53.9) reactions per 100,000 units of FFP issued. The rate of FFP-related HTRs progressively increased over the study period, from 28.7 (95% CI 22.8-36.0) in 2000 to 88.9 (78.8-100.3) reactions per 100,000 units of FFP issued in 2018 (OR 1.08 [1.07 - 1.09], P < .001), whereas the rate of other types of adverse transfusion reactions (ATRs) decreased. Between 2000 and 2014, its period of use, Solvent-Detergent-treated Apheresis FFP (SD-APH) was associated with the lowest risk of HTR. Our results indicate that although the rate of HTRs to FFP is low in France, the risk of having such a reaction has steadily increased between 2000 and 2018. A declarative bias is unlikely as the rate of other type of FFP-related ATRs decreased over the same period. The risk of HTRs to FFP is suggested to differ according to the processing of the FFP with a lower risk for SD-APH.