title: Intravenous immunoglobulin-associated thrombosis: is it such a rare event? Report of a pediatric case and of the Quebec Hemovigilance System.
abstract: BACKGROUND
  Intravenous 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.
  
  
  METHODS
  This study was a retrospective review of QHS database of IVIG-related thrombotic complications since 2003, including a case report of a pediatric patient.
  
  
  RESULTS
  QHS 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 100,000 g of IVIG given). The single pediatric case occurred in a 16-year-old female receiving IVIG for severe immune thrombocytopenia.
  
  
  CONCLUSIONS
  Thrombosis 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.
authors.affiliation: Department of Paediatric Hematology-Oncology, Sainte Justine Hospital, Montreal, Quebec, Canada.
authors.forename: Joy
authors.initials: J
authors.lastname: Benadiba
authors.forename: Nancy
authors.initials: N
authors.lastname: Robitaille
authors.forename: Gilles
authors.initials: G
authors.lastname: Lambert
authors.forename: Nawej Karl
authors.initials: NK
authors.lastname: Itaj
authors.forename: Yves
authors.initials: Y
authors.lastname: Pastore
mesh_terms: D000293:Adolescent; D000368:Aged; D001327:Autoimmune Diseases / Q000628:therapy; D058731:Blood Safety; D003278:Contraceptives, Oral, Hormonal / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006261:Headache / Q000209:etiology; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects*; D015994:Incidence; D008582:Meningitis, Aseptic / Q000209:etiology; D008595:Menorrhagia / Q000188:drug therapy / Q000209:etiology; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000628:therapy; D011792:Quebec / Q000453:epidemiology; D012008:Recurrence; D012189:Retrospective Studies; D020225:Sagittal Sinus Thrombosis / Q000453:epidemiology / Q000209:etiology*; D054063:Superior Sagittal Sinus; D019851:Thrombophilia / Q000453:epidemiology / Q000209:etiology; D014786:Vision Disorders / Q000209:etiology
chemical_list: D003278:Contraceptives, Oral, Hormonal; D016756:Immunoglobulins, Intravenous; D011241:Prednisone