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

Journal Article (Journal Article)

BACKGROUND AND PURPOSE: 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. METHODS: 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. RESULTS: 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

Full Text

Duke Authors

Cited Authors

  • Zakarija, A; Bandarenko, N; Pandey, DK; Auerbach, A; Raisch, DW; Kim, B; Kwaan, HC; McKoy, JM; Schmitt, BP; Davidson, CJ; Yarnold, PR; Gorelick, PB; Bennett, CL

Published Date

  • February 2004

Published In

Volume / Issue

  • 35 / 2

Start / End Page

  • 533 - 537

PubMed ID

  • 14707231

Electronic International Standard Serial Number (EISSN)

  • 1524-4628

Digital Object Identifier (DOI)

  • 10.1161/01.STR.0000109253.66918.5E


  • eng

Conference Location

  • United States