Have deaths ever resulted from intravascular hemolysis secondary to transfusing Rh positive patients with RhIG to treat ITP?

Between April 1996 and April 1999, 15 cases that involved the acute onset of IVH following treatment of Rh positive ITP patients with WinRhoTM were reported to the FDA. An additional 26 cases were reported to FDA between May and October 1999 and are being further evaluated.

The 15 cases included four patients who died, one of whom died from complications secondary to IVH-induced anemia. The role of RhIG in the other deaths is unknown.