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Thromboembolic events associated with immunoglobulin treatment
Objective Due to an increasing number of reported thromboembolic events (TEE) after the administration of one intravenous immunoglobulin (IVIG) and one subcutaneous immunoglobulin (SCIG), pharmacovigilance and laboratory data were collected to analyse the root cause and assess the reporting frequenc...
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| Published in: | Vox sanguinis 2013-07, Vol.105 (1), p.54-64 |
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| Main Authors: | , , , , , , , |
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| Language: | English |
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| cites | cdi_FETCH-LOGICAL-c4245-72e4edf308061d7533c1959631e72435751c2b154c0993df647fd980e2ae0d8d3 |
| container_end_page | 64 |
| container_issue | 1 |
| container_start_page | 54 |
| container_title | Vox sanguinis |
| container_volume | 105 |
| creator | Funk, M. B. Gross, N. Gross, S. Hunfeld, A. Lohmann, A. Guenay, S. Hanschmann, K. M. Keller-Stanislawski, B. |
| description | Objective
Due to an increasing number of reported thromboembolic events (TEE) after the administration of one intravenous immunoglobulin (IVIG) and one subcutaneous immunoglobulin (SCIG), pharmacovigilance and laboratory data were collected to analyse the root cause and assess the reporting frequency of TEEs for various IG products.
Methods
Paul‐Ehrlich‐Institut retrospectively analysed 228 reports of TEEs associated with six different IG products and estimated annual TEE‐reporting rates based on worldwide sale figures over a period of 6 years (2006–2011). In addition, non‐activated partial thromboplastin time (NAPTT) testing was performed to capture pro‐coagulant potential of six IG products (four IVIG and two SCIG).
Results
For three IVIGs, the drug‐related TEE‐reporting rates remained stable from 2006 to 2011 (0–0·83 cases per 1000 kg IVIG distributed). In contrast, the TEE rate of one IVIG increased significantly from 0·33 cases in 2006 to nearly nine cases in 2010 (P 200 s and a NAPTT ratio >0·8, whereas TEE‐associated batches of IG products with an increased TEE rate had a NAPTT ratio |
| doi_str_mv | 10.1111/vox.12025 |
| format | article |
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Due to an increasing number of reported thromboembolic events (TEE) after the administration of one intravenous immunoglobulin (IVIG) and one subcutaneous immunoglobulin (SCIG), pharmacovigilance and laboratory data were collected to analyse the root cause and assess the reporting frequency of TEEs for various IG products.
Methods
Paul‐Ehrlich‐Institut retrospectively analysed 228 reports of TEEs associated with six different IG products and estimated annual TEE‐reporting rates based on worldwide sale figures over a period of 6 years (2006–2011). In addition, non‐activated partial thromboplastin time (NAPTT) testing was performed to capture pro‐coagulant potential of six IG products (four IVIG and two SCIG).
Results
For three IVIGs, the drug‐related TEE‐reporting rates remained stable from 2006 to 2011 (0–0·83 cases per 1000 kg IVIG distributed). In contrast, the TEE rate of one IVIG increased significantly from 0·33 cases in 2006 to nearly nine cases in 2010 (P < 0·001).
The NAPTT testing of IG products with a low TEE rate revealed a NAPTT time >200 s and a NAPTT ratio >0·8, whereas TEE‐associated batches of IG products with an increased TEE rate had a NAPTT ratio <0·8. After modifications of manufacturing processes, a normalization of NAPTT results and a decrease in TEE rates could be demonstrated.</description><identifier>ISSN: 0042-9007</identifier><identifier>EISSN: 1423-0410</identifier><identifier>DOI: 10.1111/vox.12025</identifier><identifier>PMID: 23398249</identifier><identifier>CODEN: VOSAAD</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Child ; Correlation analysis ; Data processing ; Embolisms ; Female ; frequency ; Humans ; immunoglobulin - severity ; Immunoglobulins ; Immunoglobulins, Intravenous - administration & dosage ; Immunoglobulins, Intravenous - adverse effects ; Immunologic Factors - administration & dosage ; Immunologic Factors - adverse effects ; Immunotherapy ; IVIG - corrective actions ; Male ; Middle Aged ; NAPTT ; pharmacovigilance ; Retrospective Studies ; Thromboembolic events ; Thromboembolism - chemically induced ; Thromboembolism - epidemiology ; Thromboembolism - prevention & control ; Thrombosis ; Young Adult</subject><ispartof>Vox sanguinis, 2013-07, Vol.105 (1), p.54-64</ispartof><rights>2013 International Society of Blood Transfusion</rights><rights>2013 International Society of Blood Transfusion.</rights><rights>Vox Sanguinis © 2013 International Society of Blood Transfusion</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4245-72e4edf308061d7533c1959631e72435751c2b154c0993df647fd980e2ae0d8d3</citedby><cites>FETCH-LOGICAL-c4245-72e4edf308061d7533c1959631e72435751c2b154c0993df647fd980e2ae0d8d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23398249$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Funk, M. B.</creatorcontrib><creatorcontrib>Gross, N.</creatorcontrib><creatorcontrib>Gross, S.</creatorcontrib><creatorcontrib>Hunfeld, A.</creatorcontrib><creatorcontrib>Lohmann, A.</creatorcontrib><creatorcontrib>Guenay, S.</creatorcontrib><creatorcontrib>Hanschmann, K. M.</creatorcontrib><creatorcontrib>Keller-Stanislawski, B.</creatorcontrib><title>Thromboembolic events associated with immunoglobulin treatment</title><title>Vox sanguinis</title><addtitle>Vox Sang</addtitle><description>Objective
Due to an increasing number of reported thromboembolic events (TEE) after the administration of one intravenous immunoglobulin (IVIG) and one subcutaneous immunoglobulin (SCIG), pharmacovigilance and laboratory data were collected to analyse the root cause and assess the reporting frequency of TEEs for various IG products.
Methods
Paul‐Ehrlich‐Institut retrospectively analysed 228 reports of TEEs associated with six different IG products and estimated annual TEE‐reporting rates based on worldwide sale figures over a period of 6 years (2006–2011). In addition, non‐activated partial thromboplastin time (NAPTT) testing was performed to capture pro‐coagulant potential of six IG products (four IVIG and two SCIG).
Results
For three IVIGs, the drug‐related TEE‐reporting rates remained stable from 2006 to 2011 (0–0·83 cases per 1000 kg IVIG distributed). In contrast, the TEE rate of one IVIG increased significantly from 0·33 cases in 2006 to nearly nine cases in 2010 (P < 0·001).
The NAPTT testing of IG products with a low TEE rate revealed a NAPTT time >200 s and a NAPTT ratio >0·8, whereas TEE‐associated batches of IG products with an increased TEE rate had a NAPTT ratio <0·8. After modifications of manufacturing processes, a normalization of NAPTT results and a decrease in TEE rates could be demonstrated.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Child</subject><subject>Correlation analysis</subject><subject>Data processing</subject><subject>Embolisms</subject><subject>Female</subject><subject>frequency</subject><subject>Humans</subject><subject>immunoglobulin - severity</subject><subject>Immunoglobulins</subject><subject>Immunoglobulins, Intravenous - administration & dosage</subject><subject>Immunoglobulins, Intravenous - adverse effects</subject><subject>Immunologic Factors - administration & dosage</subject><subject>Immunologic Factors - adverse effects</subject><subject>Immunotherapy</subject><subject>IVIG - corrective actions</subject><subject>Male</subject><subject>Middle Aged</subject><subject>NAPTT</subject><subject>pharmacovigilance</subject><subject>Retrospective Studies</subject><subject>Thromboembolic events</subject><subject>Thromboembolism - chemically induced</subject><subject>Thromboembolism - epidemiology</subject><subject>Thromboembolism - prevention & control</subject><subject>Thrombosis</subject><subject>Young Adult</subject><issn>0042-9007</issn><issn>1423-0410</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNqFkEtL5UAQhRtR9HqdhX9AAm7GRbT6dbt7I6iMDxAfcMeZXZObVLQ1SWt34uPf23rVhTBMFUVtvnPgHELWKWzTNDuP_nmbMmBygYyoYDwHQWGRjAAEyw2AWiGrMd4CgGZaLpMVxrnRTJgR2Z3eBN_OPKZrXJnhI3Z9zIoYfemKHqvsyfU3mWvbofPXjZ8NjeuyPmDRt4lcI0t10UT88fHH5Pfhr-nBcX56fnRysHeal4IJmSuGAquag4YJrZTkvKRGmgmnqJjgUklashmVogRjeFVPhKorowFZgVDpio_Jz7nvffAPA8beti6W2DRFh36Ilgqa4hiVgv0X5YqBMmkTuvkNvfVD6FKQNwq05jrdmGzNqTL4GAPW9j64tggvloJ969-m_u17_4nd-HAcZi1WX-Rn4QnYmQNPrsGXfzvZq_O_n5b5XOFij89fiiLc2YniSto_Z0d2erk_Pby4vLL7_BVappyj</recordid><startdate>201307</startdate><enddate>201307</enddate><creator>Funk, M. B.</creator><creator>Gross, N.</creator><creator>Gross, S.</creator><creator>Hunfeld, A.</creator><creator>Lohmann, A.</creator><creator>Guenay, S.</creator><creator>Hanschmann, K. M.</creator><creator>Keller-Stanislawski, B.</creator><general>Blackwell Publishing Ltd</general><general>S. Karger AG</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T5</scope><scope>7TM</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope></search><sort><creationdate>201307</creationdate><title>Thromboembolic events associated with immunoglobulin treatment</title><author>Funk, M. B. ; Gross, N. ; Gross, S. ; Hunfeld, A. ; Lohmann, A. ; Guenay, S. ; Hanschmann, K. M. ; Keller-Stanislawski, B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4245-72e4edf308061d7533c1959631e72435751c2b154c0993df647fd980e2ae0d8d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Child</topic><topic>Correlation analysis</topic><topic>Data processing</topic><topic>Embolisms</topic><topic>Female</topic><topic>frequency</topic><topic>Humans</topic><topic>immunoglobulin - severity</topic><topic>Immunoglobulins</topic><topic>Immunoglobulins, Intravenous - administration & dosage</topic><topic>Immunoglobulins, Intravenous - adverse effects</topic><topic>Immunologic Factors - administration & dosage</topic><topic>Immunologic Factors - adverse effects</topic><topic>Immunotherapy</topic><topic>IVIG - corrective actions</topic><topic>Male</topic><topic>Middle Aged</topic><topic>NAPTT</topic><topic>pharmacovigilance</topic><topic>Retrospective Studies</topic><topic>Thromboembolic events</topic><topic>Thromboembolism - chemically induced</topic><topic>Thromboembolism - epidemiology</topic><topic>Thromboembolism - prevention & control</topic><topic>Thrombosis</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Funk, M. B.</creatorcontrib><creatorcontrib>Gross, N.</creatorcontrib><creatorcontrib>Gross, S.</creatorcontrib><creatorcontrib>Hunfeld, A.</creatorcontrib><creatorcontrib>Lohmann, A.</creatorcontrib><creatorcontrib>Guenay, S.</creatorcontrib><creatorcontrib>Hanschmann, K. M.</creatorcontrib><creatorcontrib>Keller-Stanislawski, B.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Vox sanguinis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Funk, M. B.</au><au>Gross, N.</au><au>Gross, S.</au><au>Hunfeld, A.</au><au>Lohmann, A.</au><au>Guenay, S.</au><au>Hanschmann, K. M.</au><au>Keller-Stanislawski, B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Thromboembolic events associated with immunoglobulin treatment</atitle><jtitle>Vox sanguinis</jtitle><addtitle>Vox Sang</addtitle><date>2013-07</date><risdate>2013</risdate><volume>105</volume><issue>1</issue><spage>54</spage><epage>64</epage><pages>54-64</pages><issn>0042-9007</issn><eissn>1423-0410</eissn><coden>VOSAAD</coden><abstract>Objective
Due to an increasing number of reported thromboembolic events (TEE) after the administration of one intravenous immunoglobulin (IVIG) and one subcutaneous immunoglobulin (SCIG), pharmacovigilance and laboratory data were collected to analyse the root cause and assess the reporting frequency of TEEs for various IG products.
Methods
Paul‐Ehrlich‐Institut retrospectively analysed 228 reports of TEEs associated with six different IG products and estimated annual TEE‐reporting rates based on worldwide sale figures over a period of 6 years (2006–2011). In addition, non‐activated partial thromboplastin time (NAPTT) testing was performed to capture pro‐coagulant potential of six IG products (four IVIG and two SCIG).
Results
For three IVIGs, the drug‐related TEE‐reporting rates remained stable from 2006 to 2011 (0–0·83 cases per 1000 kg IVIG distributed). In contrast, the TEE rate of one IVIG increased significantly from 0·33 cases in 2006 to nearly nine cases in 2010 (P < 0·001).
The NAPTT testing of IG products with a low TEE rate revealed a NAPTT time >200 s and a NAPTT ratio >0·8, whereas TEE‐associated batches of IG products with an increased TEE rate had a NAPTT ratio <0·8. After modifications of manufacturing processes, a normalization of NAPTT results and a decrease in TEE rates could be demonstrated.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>23398249</pmid><doi>10.1111/vox.12025</doi><tpages>11</tpages></addata></record> |
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| identifier | ISSN: 0042-9007 |
| ispartof | Vox sanguinis, 2013-07, Vol.105 (1), p.54-64 |
| issn | 0042-9007 1423-0410 |
| language | eng |
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| source | Wiley |
| subjects | Adult Aged Aged, 80 and over Child Correlation analysis Data processing Embolisms Female frequency Humans immunoglobulin - severity Immunoglobulins Immunoglobulins, Intravenous - administration & dosage Immunoglobulins, Intravenous - adverse effects Immunologic Factors - administration & dosage Immunologic Factors - adverse effects Immunotherapy IVIG - corrective actions Male Middle Aged NAPTT pharmacovigilance Retrospective Studies Thromboembolic events Thromboembolism - chemically induced Thromboembolism - epidemiology Thromboembolism - prevention & control Thrombosis Young Adult |
| title | Thromboembolic events associated with immunoglobulin treatment |
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