Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010.

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. STUDY DESIGN AND METHODS: This is a retrospec-tive 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 prod-ucts were identified by recorded Healthcare Common Procedure Coding System codes. TEs were ascertained via International Classification of Diseases, Ninth Revi-sion, 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 prod-ucts 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 dif-ferent 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). CONCLUSION: The study suggests potentially elevated TE rates for different IG products, including subcutane-ous. It also identifies important recipient TE risk factors and suggests that risk-benefit profiles should be weighed before IG administration. The observed differ-ences may be due to various factors such as dosage, administration rates, and product manufacturing pro-cesses that warrant further evaluation. [ABSTRACT FROM AUTHOR]