| アブストラクト | 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. |
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| ジャーナル名 | Pharmacoepidemiology and drug safety |
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| 投稿日 | 2010/07/28 |
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| 投稿者 | McMahon, Ann W; Pratt, Robert G; Hammad, Tarek A; Kozlowski, Steven; Zhou, Esther; Lu, Susan; Kulick, Corrinne G; Mallick, Tarun; Dal Pan, Gerald |
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| 組織名 | Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research,;Food and Drug Administration, Silver Spring, MD 20993, USA.;ann.mcmahon@fda.hhs.gov |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/20661880/ |
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