Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin

Project Title Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin
Date
Tuesday, July 14, 2015
Location
Description

This article describes a project that used Mini-Sentinel data to expand FDA’s understanding of hemolysis post- intravenous immune globulin (IGIV) administration.

Medical Product
intravenous immune globulin (IGIV)
Health Outcome
hemolysis
Corresponding Author

S. Winiecki, FDA Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO71-1025, Silver Spring, MD; e-mail: scott.winiecki@fda.hhs.gov

Authors

Scott K. Winiecki MD; Bethany Baer MD; Wambui Chege MD; Christopher Jankosky MD; Paul D. Mintz MD; Meghan A. Baker MD, ScD; Tiffany S. Woodworth MPH; Michael D. Nguyen MD