Safety of antithrombotic therapy in elderly patients: analysis of the Russian Pharmacovigilance Database

Abstract

The article discusses the safety issues of the use of antithrombotic drugs in elderly patients. We analyzed ADR reports submitted to the Russian Spontaneous Report Database from January 2008 to June 2018. The recommendations by the European Medical Agency was used to identify potential statistical signals of disproportionate reporting. The indicators ROR (Reporting Odds Ratio), PRR (Proportional Reporting Ratio) were calculated. We identified 314 statistical safety signals for the use of antithrombotic drugs in elderly patients. Most of the statistical signals were identified for known, predicted ADRs. About half of the signals (44,6 %) concerned hemorrhagic ADRs.