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Background Different immune-related adverse events (irAEs) were described with immune checkpoint inhibitors (ICIs), including blockers of cytotoxic T-lymphocyte associated protein 4 (CTLA4) and programmed cell death 1 or its ligand (PD1/PDL1), although their global safety is incompletely characterized.Objective To characterize spectrum, frequency and clinical features of ICI-related adverse events (AEs) reported to the FDA Adverse Event Reporting System (FAERS). Patients and MethodsAEs from FAERS (up to June 2018) recording ICIs (ipilimumab, nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab) as suspect were extracted. Comprehensive disproportionality analyses were performed through the reporting odds ratio (ROR) with 95% confidence interval (95%CI), using other oncological drugs as comparison. An overview of systematic reviews (OoSRs) was also undertaken to identify irAEs with consistent positive associations. ResultsICIs were recorded in 47,266 reports, submitted mainly by consumers receiving monotherapy with anti-PD1/PDL1 drugs. Three areas of toxicity emerged from both disproportionality and OoSRs (33 studies):

These real-world pharmacovigilance findings suggest that DILI might be a common feature of MS drugs and call for (1) formal population-based study to verify the risk of fampridine and (2) awareness by clinicians, who should assess the possible responsibility of MS drugs when they diagnose DILI.

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Notwithstanding recognized limitations, these findings strengthen the importance of exploring multiple databases in safety assessment of RYR products, which should be monitored by clinicians for muscular and hepatic safety, and call for urgent review by policymakers to harmonize their regulatory status.

Purpose: Antidepressant consumption has risen in recent years, driven by longer treatment duration. The objective of this study was to measure the prevalence of antidepressant longterm and chronic use in the Bologna area, Italy, and to identify their main determinants. Materials and Methods: We conducted a retrospective claims-based cohort study by using the Bologna Local Health Authority data. A cohort of 18,307 incident users of antidepressant drugs in 2013 was selected, and subjects were followed for three years. A long-term utilization was defined as having at least one prescription claimed during each year of follow-up, while chronic utilization was defined as claiming at least 180 defined daily doses per year. Factors associated with chronic and long-term use were identified by univariate and multivariate logistic regressions. Results: In our cohort, 5448 (29.8%) and 1817 (9.9%) subjects were dispensed antidepressants for a long-term course and in a chronically way, respectively. Older age, antidepressant polytherapy, polypharmacy, and being prescribed the first antidepressant by a hospital physician were all factors independently associated with chronic and long-term prescriptions of antidepressant drugs. Results were reported separately for men and women. Conclusion: Antidepressant long-term and chronic prescriptions are common in the Bologna area. Because longer treatment should be clinically motivated, these results strongly prompt the need to evaluate the actual relevance, as they may indicate potentially inappropriate prescription patterns.

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Purpose This study aims to describe factors associated to treatment continuity and psychiatric relapses in patients treated with Long Acting Injectable antipsychotics (LAIs) in Bologna Community Mental Health Centers (CMHCs). Methods New LAI treatments administered between July 1, 2010 and June 30, 2015 in CMHCs were selected. The cohort was followed-up for 6 months; predictors of continuity and psychiatric admissions were investigated by using logistic regression- and Cox- analysis respectively. Results Among the cohort of 1 070 patients, only 222 (21%) continued LAI treatment during the follow-up. LAI continuity was higher with first generation agents (OR: 1.71, 95%CI 1.18–2.49) and in case of previous psychiatric hospitalizations (OR 2.00, 95%CI 1.47–2.74). Incidence of psychiatric hospital admissions showed a sharp reduction in the follow-up compared with 6-month period before initiation (from 458 to 212), and was associated with previous psychiatric hospitalizations (HR 3.20, 95%CI 2.22–4.59), immigration (HR 3.13, 95%CI 1.28–7.69) and LAI discontinuation (HR 1.14, 95%Cl 1.01–1.97). Conclusions Psychiatric hospital admission before LAI initiation was the main predictor both of LAI continuity and hospitalization during the follow-up.