title: Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010.
abstract: BACKGROUND
  Thrombotic events (TEs) are rare but often serious adverse events that could occur after administration of immune globulin (IG) products. Our study objective was to assess occurrence of recorded TEs after administration of different US-licensed IG products and investigate potential risk factors using a large administrative database.
  
  
  METHODS
  This is a retrospective claims-based cohort study of individuals exposed to IG products from January 1, 2008, through September 30, 2010, using HealthCore's Integrated Research Database, a longitudinal health care database. IG products were identified by recorded Healthcare Common Procedure Coding System codes. TEs were ascertained via International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for same-day TEs by IG product, while controlling for confounders.
  
  
  RESULTS
  Of 11,785 individuals exposed to IG products in the study period, 122 (1%) had TE(s) recorded on the same day as IG administration. TE rates per 1000 persons exposed ranged from 6.1 to 20.5 for different IG product groups. Vivaglobin users had an increased same-day TE risk compared to reference Gammagard Liquid users (OR, 3.56; 95% CI, 1.54-8.23). An increased TE risk was also found with older age (≥ 45 years), prior TE(s), and hypercoagulable state(s).
  
  
  CONCLUSIONS
  The study suggests potentially elevated TE rates for different IG products, including subcutaneous. It also identifies important recipient TE risk factors and suggests that risk-benefit profiles should be weighed before IG administration. The observed differences may be due to various factors such as dosage, administration rates, and product manufacturing processes that warrant further evaluation.
authors.affiliation: HealthCore, Inc, Alexandria, Virginia, USA. medha.sasane@novartis.com
authors.forename: Gregory W
authors.initials: GW
authors.lastname: Daniel
authors.forename: Mikhail
authors.initials: M
authors.lastname: Menis
authors.forename: Gayathri
authors.initials: G
authors.lastname: Sridhar
authors.forename: Dorothy
authors.initials: D
authors.lastname: Scott
authors.forename: Anna E
authors.initials: AE
authors.lastname: Wallace
authors.forename: Mikhail V
authors.initials: MV
authors.lastname: Ovanesov
authors.forename: Basil
authors.initials: B
authors.lastname: Golding
authors.forename: Steven A
authors.initials: SA
authors.lastname: Anderson
authors.forename: Jay
authors.initials: J
authors.lastname: Epstein
authors.forename: David
authors.initials: D
authors.lastname: Martin
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.forename: Hector S
authors.initials: HS
authors.lastname: Izurieta
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D054598:Blue Cross Blue Shield Insurance Plans / Q000706:statistics & numerical data; D002648:Child; D015897:Comorbidity; D016208:Databases, Factual / Q000706:statistics & numerical data; D004198:Disease Susceptibility; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006801:Humans; D006949:Hyperlipidemias / Q000453:epidemiology; D006973:Hypertension / Q000453:epidemiology; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects*; D007249:Inflammation / Q000453:epidemiology; D038801:International Classification of Diseases; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology; D012189:Retrospective Studies; D012307:Risk Factors; D019851:Thrombophilia / Q000453:epidemiology; D013927:Thrombosis / Q000453:epidemiology / Q000209:etiology*; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D016756:Immunoglobulins, Intravenous