rFVIIa seems to help the vast majority with postpartum hemorrhage

February 21, 2008

Recombinant activated factor VII (rFVIIa) improves severe primary postpartum hemorrhage in 80% of women in whom it is used as treatment-in many cases after a single dose-and in 75% of women in whom it is used as prophylaxis, with few adverse effects, according to findings from the Northern European Registry. Four cases of thromboembolism, one myocardial infarction, and one skin rash occurred as a result of rFVIIa administration.

Recombinant activated factor VII (rFVIIa) improves severe primary postpartum hemorrhage in 80% of women in whom it is used as treatment-in many cases after a single dose-and in 75% of women in whom it is used as prophylaxis, with few adverse effects, according to findings from the Northern European Registry. Four cases of thromboembolism, one myocardial infarction, and one skin rash occurred as a result of rFVIIa administration.

Researchers collected data on women with obstetric hemorrhage between the years 2000 to 2004 from nine European countries. Most of the cases were of a sort in which all other conventional measures were failing. In fact, rFVIIa treatment failed, too, in 15 cases (13.8%). Even with the treatment, 82 women were admitted to intensive care units, five of 113 women died, and about half required laparotomy (including hysterectomy in 33 cases).

While the authors of the review were careful not to comment on the true efficacy of rFVIIa without an adequate control group, the agent seems to provide significant benefit for a lot of women.

Alfirevic Z, Elbourne D, Pavord S, et al. Use of recombinant activated factor VII in primary postpartum hemorrhage: the Northern European Registry 2000-2004. Obstet Gynecol. 2007;110:1270-1278.

Commentary from Sharon T. Phelan, MD, Professor, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.

Life-threatening postpartum hemorrhage that does not respond to typical medical or surgical intervention is uncommon, but can be deadly. The off-label use of activated factor VII has been recommended with little data to support it, but a randomized study is clearly not an option. This international summary provides more support as to the role of this intervention to deal with peripartum hemorrhage, which in turn may save lives and prevent peripartum hysterectomies.