Search

Objective: Paliperidone palmitate is a second-generation antipsychotic that has undergone extensive investigation in clinical trials. However, real-world studies assessing its safety in large populations are lacking. As such, this study aimed to comprehensively evaluate real-world adverse drug events (ADEs) linked to paliperidone palmitate by employing data mining techniques on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database. Methods: The study retrieved ADE reports from the FAERS database covering the period from 2009 through the third quarter of 2024, and from the JADER database covering the period from 2013 through the second quarter of 2024. Utilizing disproportionality analyses such as the reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item Poisson shrinkage (MGPS), significant associations between ADEs and paliperidone palmitate were evaluated. Results: A total of 27,672 ADE reports related to paliperidone palmitate were identified in FAERS, with 285 significantly disproportionate preferred terms (PTs) identified by all four algorithms. Paliperidone palmitate-associated ADEs encompassed 27 System Organ Classes (SOCs). The top three PTs with the highest reported cases were off-label use, drug ineffective, and hospitalization. Common ADEs included increased blood prolactin, galactorrhea, and schizophrenia, which was consistent with drug label. Noteworthy, unexpected signals not listed in the drug label were also identified, such as psychosexual disorders, prolactin-producing pituitary tumors, suicide attempt, and sudden death. The median onset time for all ADEs was 40 days. Furthermore, gender-based difference in risk signals was detected. Females are more likely to experience elevated blood prolactin and weight increase, whereas males are more prone to sexual dysfunction. Among the 1,065 ADE reports from the JADER database, we identified 51 positive signals, 35 of which overlapped with those found in FAERS, including schizophrenia, hyperprolactinemia, and erectile dysfunction. Conclusion: The study findings from two independent databases serve as crucial references for ensuring the safe of paliperidone palmitate. Additionally, the gender-specific monitoring references provided can enhance clinical surveillance efforts and facilitate more effective risk identification. [ABSTRACT FROM AUTHOR]

Background: Mental health consequences of the COVID-19 pandemic have been a major research focus since its beginning. A specific vulnerability of patients with borderline personality disorder (BPD) following social distancing measures has been reported, however there is a lack of adequately sized studies that provide evidence of this vulnerability. Suicide attempts may reflect mental health effects of the COVID-19 pandemic in psychiatric settings. Methods: Retrospective follow-up analysis of clinical documentation in a psychiatric emergency department (pED) of a major academic psychiatric hospital in Berlin, Germany. Observation periods include the first- (3/2/2020–5/24/2020) and second-wave (9/15/2020–3/1/2021) of the COVID-19 pandemic in Germany and respective periods one year earlier as control-periods. Poisson-regression was used for statistical modelling of individual counts of pED presentations after a suicide attempt. Results: N = 4110 patients attended the pED during the four observation periods. BPD patients were associated with elevated risk of pED presentation after a suicide attempt during COVID-periods (RR = 3.4; p =.014). Schizophrenia and psychotic disorders showed lower risk of pED presentation after a suicide attempt during COVID-periods (RR = 0.4; p =.048). Other diagnostic groups did not show significant interaction effects with COVID-periods. The first-wave was a risk factor for pED presentation after a suicide attempt affecting the sample across all diagnostic groups (RR = 3.1; p =.006). Conclusions: BPD patients seem to be particularly vulnerable during the COVID-19 pandemic showing increased rates of suicide attempts during both COVID-periods. This should be addressed in future health crises by ensuring availability of psychosocial help. There is a need for further research regarding BPD patients in public health crisis situations. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has impacted many aspects of everyday life, including the (mental) healthcare system. An increase in depression and anxiety symptoms has been reported worldwide, and is particularly pronounced in females and young people. We aimed to evaluate changes in prescription rates for psychopharmacological medication, which is often used to treat depression and anxiety. Method: Based on data from the Austrian public health insurance institutions, we conducted an interrupted time series analysis of antidepressants and antipsychotics, comparing prescription rate developments before and throughout the COVID-19 pandemic (2013 to 2021), with a special focus on adolescents (10–19 years) in comparison to the general population. Data were based on all public prescriptions in the outpatient sector nationwide. Age- and sex-stratified time-series models were fitted to the pre-COVID period (first quarter (Q1) of 2013 to second quarter (Q2) of 2020). These were used to generate forecasts for the period from the third quarter (Q3) of 2020 to the fourth quarter (Q4) of 2021, which were subsequently compared to observed developments in order to assess significant deviations from the forecasted development paths. Results: For the majority of the evaluated period, we found a significant excess of antidepressant prescriptions among both male and female adolescents (10–14 and 15–19 years) compared to the forecasted development path, while the general population was mostly within 97.5% confidence intervals of the forecasts. Regarding antipsychotics, the interrupted time series analysis revealed a significant excess in the group of female adolescents in almost all quarters, which was especially pronounced in the 15–19 age group. Prescription rates of antipsychotics in the general population only showed a significant excess in two quarters. Conclusion: Increased rates of adolescents receiving psychopharmacological treatment echo the epidemiological trends of an increase in depression and anxiety symptoms reported in the literature. This increase is especially pronounced in female adolescents. [ABSTRACT FROM AUTHOR]

The article focuses on a study regarding antidepressant consumption, suicide rates and admission for depression in the Veneto Region, Italy. The study found that suicide rates were stable in males and females and did not show any marked increase. Over the period, antidepressant prescribing increased exponentially.