Outbreak of hepatitis C associated with intravenous immunoglobulin administration--United States, October 1993-June 1994

Abstract

On February 21, 1994, the Food and Drug Administration (FDA) was notified of 14 possible cases from three different countries of acute hepatitis C among persons who had received Gammagard, an intravenous immunoglobulin (IGIV) product manufactured by Baxter Healthcare Corporation (Glendale, California). The company removed Gammagard from the worldwide market on February 23, 1994. The American Red Cross removed Polygam (IGIV manufactured by Baxter Healthcare from American Red Cross plasma) from the market on the same date. This report presents preliminary findings of an evaluation of transmission of hepatitis C virus (HCV) infection from these products and guidelines for monitoring patients who may have received them.