Clopidogrel-associated TTP: an update of pharmacovigilance efforts conducted by independent researchers, pharmaceutical suppliers, and the Food and Drug Administration

Since the 1999 identification of clopidogrel-associated thrombotic thrombocytopenic purpura (TTP) through independent active surveillance, subsequent cases have been identified by pharmaceutical suppliers of clopidogrel and the Food and Drug Administration (FDA). For cases of clopidogrel-associated...

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Bibliographic Details
Published in:Stroke (1970) 2004-02, Vol.35 (2), p.533-537
Main Authors: Zakarija, Anaadriana, Bandarenko, Nicholas, Pandey, Dilip K, Auerbach, Amy, Raisch, Dennis W, Kim, Benjamin, Kwaan, Hau C, McKoy, June M, Schmitt, Brian P, Davidson, Charles J, Yarnold, Paul R, Gorelick, Philip B, Bennett, Charles L
Format: Article
Language:English
Subjects:
Adult
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Aged
Aged, 80 and over
Causality
Female
Humans
Male
Middle Aged
Plasma Exchange
Platelet Aggregation Inhibitors - adverse effects
Product Surveillance, Postmarketing - statistics & numerical data
Prognosis
Purpura, Thrombotic Thrombocytopenic - chemically induced
Purpura, Thrombotic Thrombocytopenic - diagnosis
Purpura, Thrombotic Thrombocytopenic - mortality
Purpura, Thrombotic Thrombocytopenic - therapy
Recurrence
Survival Rate
Ticlopidine - adverse effects
Ticlopidine - analogs & derivatives
Time Factors
United States - epidemiology
United States Food and Drug Administration
Citations: Items that this one cites
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Summary:Since the 1999 identification of clopidogrel-associated thrombotic thrombocytopenic purpura (TTP) through independent active surveillance, subsequent cases have been identified by pharmaceutical suppliers of clopidogrel and the Food and Drug Administration (FDA). For cases of clopidogrel-associated TTP reported between 1998 to 2002, we evaluated the quality and timeliness of data from 3 reporting systems-independent active surveillance (n=13), pharmaceutical suppliers (n=24), and the FDA (n=13)-and identified prognostic factors associated with mortality. This study assessed the completeness of information on TTP diagnosis, treatment response, and causality from the 3 reporting systems. In addition, predictors of mortality were identified through classification tree analysis. Completeness, timeliness, and certainty of diagnosis were best for cases obtained by active surveillance, intermediate for cases reported to the pharmaceutical supplier, and poorest for cases reported directly to the FDA. Clopidogrel had been used for
ISSN:0039-2499
1524-4628
DOI:10.1161/01.STR.0000109253.66918.5E