Purpose: To evaluate the drug-induced liver injury (DILI) adverse events related to antidepressants. Method: Post-marketing cases were obtained from the United States Food and Drug Administration Adverse Events Reporting System (FAERS). Disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and the information component (IC). Result: There were a total of 10,355 reported cases of DILI out of a total of 324,588 cases reported from January 2004 to December 2021. Among the 42 antidepressants assessed, nefazodone (n = 47, ROR = 7.79, IC=2.91), fluvoxamine (n = 29, ROR = 4.69, IC=2.20), and clomipramine (n = 24, ROR = 3.97, IC=1.96), were the top three compounds ranked with the highest reporting odds of cholestatic injury. Mianserin (n = 3, ROR = 21.46, IC=3.99), nefazodone (n = 264, ROR = 18.67, IC=3.84), and maprotiline (n = 15, ROR = 5.65, IC=2.39), were the top three compounds ranked with the highest reporting odds of hepatocellular injury. Nefazodone (n = 187, ROR = 12.71, IC=0.48), clomipramine (n = 35, ROR = 2.07, IC=0.26), and mirtazapine (n = 483, ROR = 1.96, IC=0.94) were the top three on drug related severe hepatic disorders. Only nefazodone detected the signals (n = 48, ROR = 18.64, IC=4.16) in the study of hepatic faliure. Conclusion: The data mining of FAERS suggested significant association between DILI and nefazodone. Duloxetine and clomipramine detected the signals on three categories of DILI besaides hepatic failure. Moreover, DILI risk on the new generation of antidepressants should also be taken into consideration.

Aims Venous thromboembolism (VTE) is a rare but serious adverse drug reaction could be caused by antipsychotic drugs. However, the specific correlation of VTE caused by antipsychotic drugs is still controversial. This study explored the potential association between antipsychotics and VTE. Method All VTE cases of antipsychotic drugs as primary suspected medicines were extracted from the US Food and Drug Administration adverse event reporting system (FAERS) from 2004 to 2021.Disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and the information component (IC). Results 4, 455 VTE cases with antipsychotics as primary suspected drugs were identified. The VTE signal was detected in 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), respectively. Pulmonary embolism occurred in more than 50% of VTE events (2760 cases, 52.84%). The outcome indicated that venous thrombosis caused by antipsychotics is usually a serious consequence. Conclusion The current data mining of FAERS suggested an association between VTE and antipsychotic drugs including olanzapine, haloperidol, paliperidone and quetiapine, which reminds health professionals to pay attention to the serious adverse drug effects of antipsychotic drugs leading to venous thromboembolism.

AIM: Proton pump inhibitors (PPIs) were widely used around the world. Studies suggested conflicting results between PPIs treatment and the risk of dementia. This study examined the association between PPIs and dementia risk by mining the US FDA Adverse Event Reporting System (FAERS) database. METHODS: We identified six PPI agents and adverse reports of dementia based on FAERS database from 2004 to 2019. We employed reporting odds ratio (ROR) and proportional reporting ratio (PRR) to detect the signals of dementia relevant to PPIs. We also analyzed characteristics of PPI reports, compared dementia events between short- and long- duration PPIs treatment. RESULTS: We identified 2104 dementia cases with PPIs treatment. We did not detect significant signals between PPIs and dementia, ROR = 0.99, 95%CI 0.94 - 1.03, PRR = 0.99, 95%CI 0.95 - 1.03, even in gastroesophageal reflux disease cases ROR = 0.65, 95%CI 0.58 - 0.73, PRR = 0.67, 95%CI 0.60 - 0.74. No significant differences of dementia events were detected between short- and long- duration groups, the OR (95%CI) of the 6 months, 1 year, 3 years and 5 years comparison were 0.85 (0.68 - 1.06), 0.92 (0.71 - 1.18), 0.81 (0.57 - 1.15) and 0.79 (0.52 - 1.22), respectively. CONCLUSIONS: Based on the current FAERS data mining, we discovered no association between PPIs use and the risk of dementia.