Ticlopidine Safety Profile: A Case/Non-Case Study on the Basis of the Spontaneous ADRs Reporting in Italy

作者：Domenico Motola, Chiara Biagi, Roberto Leone, Mauro Venegoni, Francesco Lapi, Paola Maria Cutroneo, Antonio Vargiu, Roberto Bonaiuti, Nicola Montanaro, Alberto Vaccheri · 发表于：Current Drug Safety · 年份：2012 · DOI：10.2174/157488612802715717 · 被引用次数：5 · 研究领域：Pharmacovigilance and Adverse Drug Reactions、Drug-Induced Adverse Reactions、Pharmaceutical studies and practices

UNLABELLED: INTRODUCTON: Ticlopidine is an antiplatelet agent available from several decades. Its most important adverse drug reactions (ADRs) involve haematological system. Our aim was to evaluate the safety profile of ticlopidine in the real life, on the basis of spontaneous ADR reporting. MATERIALS AND METHODS: Spontaneous reports from 8 Italian Regions collected from 1990 to March 2007 were analysed. According to WHO Adverse Reaction Terminology for causality assessment only "certain", "probable" or "possible" ADRs were included. Association between drugs and any ADR was assessed by using the case/non-case methodoloy. Reporting odds ratio (ROR) was computed as a measure of disproportionality. RESULTS: Overall, 478 reports concerning ticlopidine were analysed. The system organ classes with significant disproportionality for ticlopidine included White Cell Disorders (ROR=22.43, 95% CI 18.54-27.12), Red Cell Disorders (8.22; 6.03-11.18), Liver And Biliary System (6.67; 5.35-8.32), Platelet, Bleeding & Clotting (6.59; 5.16-8.40). Fifteen percent of the ADRs occurred beyond the first three months of ticlopidine therapy. In 386 reports (80.7%), ticlopidine was the only suspected drug. CONCLUSION: Safety profile of ticlopidine can be considered well-established in terms of ADRs type but their frequency and severity continue to be higher in its current use. Since this drug is still widely used in Italy, both healthcare providers and patients should be aware of its ADRs. More spec...