Key word
Pharmacovigilance, Pulmonary thromboembolism, Deep venous thrombosis, Venous thromboembolism, Antipsychotics
Introduction
Venous thromboembolism (VTE) includes deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT and PE are two clinical manifestations in different stages of VTE, and they share the same risk factors. VTE is the third most frequent acute cardiovascular syndrome globally, behind myocardial infarction and stroke. In some epidemiological studies, annual incidence rates for PE range from 39 to 115 per 100 000 population; for DVT, incidence rates range from 53 to 162 per 100 000 population [1, 2]. VTE has significant morbidity and mortality for both the inpatient and outpatient populations.
VTE is a heterogeneous disease. A major theory delineating the pathogenesis of VTE, often called the Virchow triad[3, 4], proposes that VTE occurs as a result of blood stasis, vascular endothelial injury, and alterations in the constituents of the blood. According to this theory, any factor that affects the three elements will lead to the occurrence of a thrombus. The causes of VTE can be divided into two groups: hereditary and acquired, and are often multiple in each patient. Medication is one of the risks acquired factors for VTE. To date, the drugs that may induce VTE include oral contraceptives, hormone replacement therapy, and chemotherapy drugs [2]. In recent years, studies have confirmed that antipsychotic medications may be associated with VTE, and patients with severe mental illness have a higher risk of developing the condition compared to the general population[5-7]. However, there are few comprehensive reports on the association between antipsychotics and venous thromboembolism.
VTE caused by antipsychotic drugs is one of the adverse drug reactions. Adverse event reporting system data are an outstanding source of post-marketing drug safety monitoring and pharmacovigilance analysis World widely. The US Food and Drug Administration’s Adverse Event Reporting System (FAERS) is one of the largest databases available to the public. By the end of 2019, FAERS had collected more than 10 million cases, including adverse drug event reports submitted by medical professionals, manufacturers, consumers, and lawyers. These reports can be quantitatively analyzed using data mining methods to detect signals of drug-related adverse events[8-9]. The purpose of this study was to detect the signal of antipsychotics causing VTE by systematically evaluating spontaneous reports submitted to the FAERS database.