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.