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

Basic Details
Date
Type
Publication
Medical Product
intravenous immune globulin (IGIV)
Health Outcome(s)
hemolysis
Description

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

Materials

Transfusion, 55: S28–S35. doi: 10.1111/trf.13116

Author(s)

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

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