Hyperimmune globulins and same-day thrombotic adverse events as recorded in a large healthcare database during 2008–2011
Article first published online: 12 SEP 2013
Copyright © 2013 Wiley Periodicals, Inc.
American Journal of Hematology
Volume 88, Issue 12, pages 1035–1040, December 2013
How to Cite
Menis, M., Sridhar, G., Selvam, N., Ovanesov, M. V., Divan, H. A., Liang, Y., Scott, D., Golding, B., Forshee, R., Ball, R., Anderson, S. A. and Izurieta, H. S. (2013), Hyperimmune globulins and same-day thrombotic adverse events as recorded in a large healthcare database during 2008–2011. Am. J. Hematol., 88: 1035–1040. doi: 10.1002/ajh.23559
- Issue published online: 22 NOV 2013
- Article first published online: 12 SEP 2013
- Accepted manuscript online: 1 AUG 2013 08:31AM EST
- Manuscript Accepted: 22 JUL 2013
- Manuscript Revised: 28 JUN 2013
- Manuscript Received: 2 MAY 2013
- U.S. Food and Drug Administration, Center for Biologics Evaluation and Research
- 18European Medicines Agency Press Release. European Medicines Agency recommends suspension of Octagam in all EU Member States; September 24, 2010. (http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/09/WC500097037.pdf). Accessed August 8, 2012.
- 19Center for Biologics and Research, FDA. Recalls (Biologics). URGENT: Voluntary Market Withdrawal—September 23, 2010 Octagam [Immune Globulin Intravenous (Human)] 5% Liquid Preparation. (http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm227133.htm). Accessed August 8, 2012.
- 20Centers for Biologics and Research, FDA. Safety & Availability (Biologics) Important Safety Information: Risk of Thrombotic Adverse Events with Subcutaneous or Inappropriate Intravenous Use of Vivaglobin (Immune Globulin Subcutaneous). (http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm246863.htm). Accessed May 25, 2012.
- 21Public Workshop: Risk Mitigation Strategies to Address Potential Procoagulant Activity in Immune Globulin Products. Transcript May 17, 2011 Rockville, Maryland. (http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM258022.pdf). Accessed August 15, 2012.
- 23Characterization of proteolytical activity in IgG—Vivaglobin. Public Workshop: Risk Mitigation Strategies to Address Potential Procoagulant Activity in Immune Globulin Products. May 17–18, 2011 Rockville, Maryland. (http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM260780.pdf). Accessed August 8, 2012..
- 32The U.S. Food and Drug Administration's Mini-Sentinel program: Status and direction. Pharmacoepidemiol Drug Saf 2012;21:1–8., , , et al.
- 33United States Census Bureau. American FactFinder. (http://factfinder2.census.gov). Accessed March 1, 2013.
- 34Epidemiology and prevention of respiratory syncytial virus infections among infants and young children. Pediatr Infect Dis J 2011;30:510–517., .
- 35Synagis® (palivizumab) injection for intramuscular use. Package Insert. (http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103770s5161lbl.pdf). Accessed February 25, 2012.
- 40Association of factor XIa with intravenous immune globulin products implicated in thrombotic adverse events: Biochemical root cause investigation. J Thromb Haemost 2011;9., , , et al.
- 44Thromboembolic events associated with intravenous immunoglobulin therapy. Neurology 1997;48:A54., , , et al.
- 49Quantitative Determination of Relevant Amounts of Blood Coagulation Factor XI acitivity in a Specific Brand of Intravenous Immunoglobulin. WebmedCentral IMMUNOTHERAPY 2011;2:WMC001922., , , et al.
- 50Laboratory investigations of products associated with thrombotic events. FDA Workshop: Risk Mitigation Strategies to Address Procoagulant Activity in Immune Globulin Products. (http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM260788.pdf). Accessed May 17, 2012..
- 51Identification of activated FXI as the major biochemical root cause in IVIG batches associated with thromboembolic events. Analytical and experimental approaches resulting in corrective and preventive measures implemented into the Octagam® manufacturing process. WebmedCentral IMMUNOTHERAPY 2011;2:WMC002002., , , et al.
- 52Important Safety Information: Potential Risk of Thrombotic Events with Use of GamaSTAN® S/D (Immune Globulin (Human)). Grifols. (http://www.hypermunes.com/media/Gamastan_ISI.pdf). Accessed August 3, 2012.
- 53Notice to Hospitals. Health Canada Endorsed Important Safety Information on HepaGam B® (Hepatitis B Immune Globulin [Human] Injection). Cangene. (http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-vis/prof/2012/hepagam_nth-aah-eng.pdf). Accessed August 3, 2012.