Recombinant activated factor VIIa for severe postpartum hemorrhage in Africa: Evidence, appropriate use, and research priorities-A narrative review.
Mahlangu Johnny J, Rhemtula Haroun H, Zamparini Jarrod J, Chauke Lawrence L
Postpartum hemorrhage (PPH) accounts for 30%-50% of maternal mortality in Africa and occurs in the context of pre-existing anemia, limited blood product availability, delayed recognition, and constrained referral systems. Although bundle-based care (E-MOTIVE), early tranexamic acid (TXA), and uterotonics have substantially improved outcomes, a small proportion of women develop refractory hemorrhage despite optimal conventional management. This narrative review evaluates the role of recombinant activated factor VIIa (rFVIIa) in severe PPH within the African context. We conducted a structured search of PubMed/MEDLINE, Embase, Scopus, and Google Scholar, which was supplemented by manual review of international guidelines. We critically evaluated and synthesized data from clinical studies, systematic reviews, registries, consensus statements, and relevant African literature. The principal evidence derives from a French-Swiss randomized controlled trial demonstrating a 40% relative reduction in invasive procedures, supported by observational studies and expert consensus. In 2022, the European Medicines Agency approved rFVIIa for severe PPH after uterotonic failure, followed by South African approval in 2023. The indication remains unapproved by the U.S. Food and Drug Administration and is off-label in most other African countries. Efficacy depends on timely administration after definitive obstetric source control and correction of coagulopathy and physiological derangements. Current evidence supports rFVIIa as a protocolized rescue adjunct rather than routine therapy. In Africa, its use should be restricted to carefully selected women with refractory PPH managed in tertiary centers with multidisciplinary expertise. African registries, pragmatic implementation studies, and health-economic evaluations are needed to define its optimal role within resource-constrained healthcare systems.