Abstract:
PURPOSE:To characterize the nature of a heparin contaminant's clinical effects in cases reported to the Adverse Event Reporting System (AERS). The FDA received reports of heparin-associated adverse events (AEs) starting in late 2007-early 2008 during a national investigation of allergic-type events. The investigation identified Baxter Healthcare-brand heparin product due to its strongest association with the events. Later, oversulfated chondroitin sulfate (OSCS), a heparin-like contaminant, was discovered. METHODS:This study was a case series of heparin reports in AERS received 1 January 2008 to 31 March 2008. Variables considered were frequency of treatment settings, AEs, mortality; as well as heparin dose and OSCS contamination. RESULTS:Five hundred seventy-four AERS cases (unduplicated reports) were identified and included. Of 94 cases with a fatal outcome, 68 reported at least one AE term from the list used to identify an allergic-type event. Nearly 75% of AEs in cases of IV administration (n = 170/233) reportedly occurred within 10 minutes, whereas over half of subcutaneous administration cases (n = 13/23) resulted in times-to-event of greater than 24 hours. Although cases with a time-to-event of less than 10 minutes appeared to correlate with higher levels of OSCS contamination, no clear differences were noted between high- and low-to-absent OSCS concentration lots with respect to AEs observed. CONCLUSIONS:Intravenous administration and a higher OSCS concentration appeared to correlate with a more rapid onset of event. The FDA continues to monitor AEs associated with heparin use and has taken appropriate regulatory action to ensure a safe heparin drug supply.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
McMahon AW,Pratt RG,Hammad TA,Kozlowski S,Zhou E,Lu S,Kulick CG,Mallick T,Dal Pan Gdoi
10.1002/pds.1991subject
Has Abstractpub_date
2010-09-01 00:00:00pages
921-33issue
9eissn
1053-8569issn
1099-1557journal_volume
19pub_type
杂志文章abstract:PURPOSE:Drug treatment of idiopathic Parkinson's disease (IPD) is a difficult task, and comorbidity and comedication add to its complexity. Since in IPD there is little information about drug use, this study investigated drug prescribing and indications in IPD patients. METHODS:From June 1997 to April 1998, a cross-se...
journal_title:Pharmacoepidemiology and drug safety
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journal_title:Pharmacoepidemiology and drug safety
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journal_title:Pharmacoepidemiology and drug safety
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
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journal_title:Pharmacoepidemiology and drug safety
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更新日期:2009-09-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
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更新日期:2009-01-01 00:00:00
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pub_type: 杂志文章
doi:10.1002/pds.1458
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更新日期:2013-11-01 00:00:00
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pub_type: 杂志文章,随机对照试验
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更新日期:2014-01-01 00:00:00
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pub_type: 杂志文章
doi:10.1002/pds.1356
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更新日期:1998-08-01 00:00:00
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更新日期:2016-03-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,meta分析
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更新日期:2013-04-01 00:00:00
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更新日期:2017-09-01 00:00:00
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pub_type: 杂志文章
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更新日期:2010-03-01 00:00:00
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更新日期:2001-08-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
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更新日期:2014-12-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2016-03-01 00:00:00
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pub_type: 杂志文章
doi:10.1002/pds.3260
更新日期:2012-05-01 00:00:00