Hemorrhage induced by Thrombolysis: new insights from a real-world pharmacovigilance study

Abstract Background: Hemorrhage represents the most common and serious side effect of thrombolytic therapy. Many studies have compared the risk of bleeding between different thrombolytic therapy, but analysis of time-to-onset for hemorrhage induced by thrombolysis is yet sparse. Methods: We conducted a retrospective study based on the adverse drug reaction reports on antithrombotic agents collected by the Henan Adverse Drug Reaction Monitoring Center. We assessed the reporting odds ratio to determine the disproportionate reporting signals for bleeding and the Weibull shape parameter was used to evaluate the time-to-onset data. Results: In the signal detection, crude low molecular weight heparin-hemorrhage was found as a positive signal. The hemorrhage for most antithrombotic agents was random failure profiles. In particular, the hazard of hemorrhage decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole. Conclusions: We found that the patients taking Crude low molecular weight heparins were more likely to bear hemorrhagic side effects, which may be attributed to the severely irrational use of this medication under improper management. The risk of bleeding decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole.