A review of postmarketing adverse experience reports (AERs) was undertaken to evaluate for a possible association between immune globulins IV (IGIVs) and acute renal failure (ARF), following inquiries from clinicians. For this review, a search of the database across all IGIVs and all ARF COSTARTs identified 40 AERs received between 1988 and 1994 that were available for review. The AERs were tabulated across the following demographic variables:sex, age, indication, medical history, concomitant medications, duration of treatment, time to onset of AER, and dechallenges/rechallenges. No patterns were apparent in the examination of these variables. The AERs were subsequently reviewed in terms of the clinical course of the reported event and were supplemented with data collected in telephone follow-up(s) with the patients and/or attending health care personnel. Neither were any patterns apparent in the examination of this data in terms of possible, probable, or definitive etiology(ies). The assessment of causality between IGIVs and ARF was thus indeterminate. However, the IGIV AERs will continue to be monitored for ARF.
