4. Results
A total of 376, 344 adverse reaction cases were reported by
antipsychiatrys as preferred suspected drugs, of which 4, 455 were VTE
cases. We tried to identify 43 antipsychotic drugs. However, only the
following twenty-four drugs were identified: olanzapine, quetiapine,
clozapine, risperidone, aripiprazole, haloperidol, paliperidone,
pimavanserin, ziprasidone, lurasidone, asenapine, lithium,
chlorpromazine, brexpiprazole, Iloperidone, droperidol,
prochlorperazine, cariprazine, thioridazine, fluphenazine, amisulpride,
ipamperone, pimozide, loxapine. The male-to-female ratio with VTE
(2125/1964) was 1.08. Most VTE cases occurred in the 18 to 64-year group
(64.29%). Health professionals reported 75.76% of VTEI cases. The top
there VTE reporting regions were Europe (2666 cases, 59.84%), North
America (1103 cases, 24.76%), and Asia (357 cases, 8.01%). The details
are in Table 1. The top ten of the most reported cases of VTE
antipsychotic drug are olanzapine, quetiapine and clozapine and
risperidone, aripiprazole, haloperidol, paliperidone, pimavanserin,
ziprasidone and lurasidone(Table 2). The data mining of FAERS suggested
an association between VTE and haloperidol, olanzapine, quetiapine, and
paliperidone. The RORs and the 95% confidence intervals (95% CI) of t
haloperidol, olanzapine, quetiapine, and paliperidone were (ROR 2.17,
95% CI 2.17-1.91 IC 1.1 95%CI 1.52-0.66), (ROR 2.53 95% CI 2.69–2.38
IC 1.31 95%CI 1.52-1.1), (ROR 1.37, 95% CI 1.47–1.28 IC 0.45 95%CI
0.67-0.23) and (ROR 1.6 95% CI 1.83–1.4 IC 0.67 95%CI 1.11-0.22). So,
clinicians should monitor patients for potential VTE while they are
taking these antipsychotic drugs.
Pulmonary embolism occurred in more than 50% of VTE events (2760 cases,
52.84%), deep vein thrombosis is 24.79%(1295 cases), and Another
non-standardized diagnosis of VTE is 22.36%(1168 cases) in Fig 1. It is
indicated that venous thrombosis caused by antipsychotics is usually a
severe consequence, which is confirmed by our analysis of the outcome,
including death (883 cases), life-threatening (693 cases),
hospitalization (1643 cases), and other serious events (1164 cases) in
Fig 2.
Signal detection
According to the chemical structure of antipsychotics, it can be divided
into butyrophenone derivatives, indole derivatives, thioxanthene
derivatives, and diphenylbutylpiperidine derivatives, phenothiazines
with aliphatic side-chain, phenothiazines with piperazine structure,
diazepines, oxazepines, thiazepines and oxepines and lithium and other
antipsychotics. Table 3 shows that Diazepines, oxazepines, thiazepines
and oxepines and diphenylbutylpiperidine derivatives antipsychotics have
the strongest signal in FARES. In terms of specific drugs, haloperidol,
olanzapine, quetiapine and paliperidone show the strongest correlation
(Table 4 for details).