Intravenous immunoglobulin-associated thrombosis: is it such a rare event? Report of a pediatric case and of the Quebec Hemovigilance System.

BackgroundIntravenous immunoglobulin (IVIG) is frequently given in autoimmune disorders. Side effects are usually mild but severe complications such as thrombosis may occur. After one patient with IVIG-associated thrombotic complication at Sainte-Justine Hospital, the incidence of serious adverse events (SAEs) reported to the Quebec Hemovigilance System (QHS) was reviewed. Study Design and MethodsThis study was a retrospective review of QHS database of IVIG-related thrombotic complications since 2003, including a case report of a pediatric patient. ResultsQHS is one of the rare national hemovigilance systems that have included IVIG reports for almost a decade. Over an extended period of 11 years (2003-2013), there have been eight cases of IVIG-related thrombosis, seven in adults and one in the pediatric population (respective rate of 0.06 case and 0.17 case per 100,000g of IVIG given). The single pediatric case occurred in a 16-year-old female receiving IVIG for severe immune thrombocytopenia. ConclusionThrombosis after IVIG is a rare though SAE occurring mostly in adults. This underlines the importance of properly reporting IVIG SAEs to improve hemovigilance data and study such rare events.