Pharmacovigilance Study of Three Intravenous Thrombolytic Drugs in the Real World

OBJECTIVE To analyze adverse drug event(ADE) data for the thrombolytic agents alteplase, tenecteplase, and reteplase(administered via injection) using the OpenVigil pharmacovigilance analysis platform to mine the FDA Adverse Event Reporting System(FAERS) database. Through systematic data mining, the findings aim to provide evidence-based guidance for clinical medication optimization and individualized treatment regimen refinement.

METHODS This study utilized the OpenVigil 2.1-MedDRA-v26.1 (data from 2004Q1 to 2023Q3) online analysis system on the OpenVigil drug surveillance data analysis website to analyze data from the FAERS for the first quarter of 2004 through the third quarter of 2023. The analysis involved extracting data related to Preferred Terms with the names "alteplase", "tenecteplase", and "reteplase". Afterwards, the reporting odds ratio and medicines and healthcare products regulatory agency methods were employed to conduct data mining on adverse reaction reports associated with alteplase, tenecteplase, and reteplase. Translated and systematically classified positive signals using the MedDRA terminology set.

RESULTS Both alteplase and tenecteplase exhibited new signals for infectious pneumonia and compartment syndrome, while alteplase demonstrated a strong signal for vascular edema, and reteplase displayed a strong signal for marfan syndrome.

CONCLUSION Novel ADE signals are detected for all 3 thrombolytic agents. Clinicians should not only monitor ADEs listed in the drug labels but also remain vigilant for unlabeled yet high-signal-strength ADEs during thrombolytic therapy to ensure both patient safety and treatment efficacy.