Human Immunoglobulins for intravenous use and hepatitis C viral transmission.

On February 23, 1994, a U.S. Food and Drug Administration (FDA)-licensed immunoglobulin intravenous (IGIV) manufacturer initiated a worldwide withdrawal of two products following an accumulation of 14 reported cases of hepatitis in American and European patients receiving one of these products. By July 1994, this number had grown to 112 in the United States alone (5). A newly licensed version of the product in question has since been introduced following the incorporation of a solvent-detergent treatment in the manufacturing process. This most recent episode has brought to light some unresolved questions concerning the past and future safety of IGIV products with respect to viral transmission in general and hepatitis C virus (HCV) in particular.