Amoxicillin is widely prescribed, either as a monotherapy or in combination with clavulanic acid, with its therapeutic indications including a broad range of infections. Its combination with clavulanic acid maintains its known activity against strains producing β-lactamase. There are limited studies on adverse reactions and antibiotic resistance, with researchers relying primarily on databanks that report spontaneous events caused by amoxicillin or the combination of amoxicillin/clavulanic acid. Antimicrobial resistance is an overlooked adverse event, and pharmacovigilance databases could serve as a tool in tracking resistance. On this basis, a study to define the safety profile of amoxicillin and amoxicillin/clavulanic acid and to increase the knowledge necessary to support the battle against antimicrobial resistance was undertaken through the analysis of pharmacovigilance databases. Suspected adverse reactions to amoxicillin and to the combination of amoxicillin/clavulanic acid in the data system EudraVigilance (2020–2024) were analyzed. The most frequent alerts concerned “Skin and subcutaneous disorders” for both drugs. Disproportionate analysis of cases concerning “Hepatobiliary disorders” or “Drug inefficiency” indicates a significant increase in these alerts with the amoxicillin/clavulanic acid combination compared to amoxicillin. The amoxicillin/clavulanic acid combination has previously been associated with a higher risk of hepatotoxicity and antibiotic resistance to amoxicillin/clavulanic acid; however, this is the first time that a post-marketing surveillance study has shown that antimicrobial resistance is more likely to occur with the combination in comparison to amoxicillin alone.

Background/Objective: Major depressive disorder (MDD) is a common mental disorder, with a significant portion of patients developing treatment-resistant depression (TRD). Esketamine is an antagonist of the N-methyl-D-aspartate receptor indicated as a nasal spray in combination with other antidepressants for adults with TRD. Signals of suspected adverse reactions (SARs) to esketamine from the EudraVigilance database in European countries were analyzed for a more defined safety profile of this drug in the real world. Methods: SARs to esketamine reported in the data system EudraVigilance were analyzed, and disproportionality analysis for adverse reactions indicating suicidality for esketamine, in comparison to the antidepressants fluoxetine and venlafaxine, was performed. Results: Increases in blood pressure (15.4%) and dissociation (15.0%) were the most frequently reported SARs. The sex distribution indicates the prevalence of women, except for increased blood pressure and completed suicide, which were signaled in men, while adults (18–64 years) and elders (65–85 years) were the ages with the largest number of reported adverse reactions to esketamine. The results indicate the existence of a potential increase in the risk of suicide in depressed patients taking esketamine when compared with fluoxetine and venlafaxine. Conclusions: Apart from carefulness due to the known limitations of pharmacovigilance research conducted by using data systems of spontaneous signals for SARs, the analysis of data points toward the need for greater attention being paid to the potential risk of suicide following the prescription of esketamine in depressed subjects. In this regard, as regulatory agencies also recommend, patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to beginning treatment should receive more careful monitoring during treatment.

Alone or combined with clavulanic acid, amoxicillin is widely prescribed. Therapeu-tic indications include a broad spectrum of infections. Combination with clavulanic acid kept the known activity of amoxicillin against strains producing β-lactamase. Only poor studies exist on adverse reactions and antibiotic resistance by using databanks reporting spontaneous signals caused by amoxicillin or the combination amoxicillin/clavulanic acid. Antimicrobial resistance is an overlooked adverse event and pharmacovigilance da-tabases could serve as a tool in tracking resistance. On this basis, a study to define the safety profile of amoxicillin and amoxicillin/clavulanic acid and to increase the knowledge necessary to support the battle against antimicrobial resistance was undertook through the analysis of pharmacovigilance databases. Signals of suspected adverse reac-tions to amoxicillin and to the combination amoxicillin/clavulanic acid of the data system EudraVigilance in the years 2020-2024, were analyzed. A disproportionality analysis for hepatotoxic reactions and for drug inefficiency was performed comparing data of the two medicinal products. Most frequent signals were about “Skin and subcutaneous disorders” for both the drugs. Disproportionate analysis of cases signaling “Hepatobiliary disor-ders” or “Drug inefficiency”, indicates significant increase of these signals with the com-bination amoxicillin/clavulanic acid compared to amoxicillin. The combination amoxicil-lin/clavulanic acid has previously been associated with higher risk of hepatotoxicity, however, it is the first time that a post-marketing surveillance shows that antimicrobial resistance has a greater probability to occur with the combination in comparison to amoxicillin.

Lymphomas represent a heterogeneous group of blood tumors, generally divided into non-Hodgkin lymphoma (NHL) (90% of all lymphomas) and Hodgkin lymphoma (HL). High-grade NHL can rapidly progress so that new strategies and potentially therapeutical options are needed. Recently, it was shown that Vitamin D (VitD) inhibits the growth of cancer cells, controls their invasion and metastasis, and strengthens the antitumor activity of various types of chemotherapeutic anticancer agents. Therefore, we reviewed the recent literature about the influence of VitD and its analogues (VDAs) on the treatment and the prognosis of B-cell lymphomas. As to the in vitro studies in different cell lines, VitD3 and VDAs enhanced the anti-proliferative efficacy of various chemotherapeutics and increased the expression of VitD receptor. In in vivo studies, blood levels of VitD were considered: higher values of plasma bioavailable VitD were correlated with better progression-free survival (PFS) and overall survival (OS), while an unfavorable PFS and OS were observed in VitD deficient groups. No clinical trial was made on the analogs, thus confirming the absence of in vivo positive role of these synthetic drugs. In conclusion, higher levels of circulating VitD are related to improved OS, reduced cancer-specific mortality, and better disease-free survival. VitD and analogs showed also positive effects in in vitro studies, while only VitD was able to improve clinical parameters. Furthermore, a complex approach with plant-based diet, adequate levels for motor exercise, and/or eventual VitD supplementation could be a valuable strategy to challenge lymphomas.

Background/ Objective: Major depressive disorder (MDD) is a common mental disorder, with a significant part of patients developing treatment-resistant depression (TRD). Esketamine is an antagonist of the N-methyl-D-aspartate receptor indicated as a nasal spray in combination with other antidepressants for adults with TRD. Signals of suspected adverse reactions (SARs) to esketamine from the EudraVigilance database in European countries were analyzed for a more defined safety profile of this drug in the real-world. Methods: SARs to esketamine reported in the data system EudraVigilance were analyzed and disproportionality analysis for adverse reactions indicating sui-cidality for esketamine, in comparison to the antidepressants fluoxetine and ven-lafaxine, was performed. Results: “Blood pressure increased” (15.4%) and “Dissocia-tion” (15.0%), are the more frequently reported SARs. Sex distribution indicates prevalence of women, except for “Blood pressure increased” and “Completed suicide”, more signaled for men, while adults (18-64 years) and elders (65-85 years) are the ages with the largest number of reported adverse reactions to esketamine. Results show a significant increase of risk of suicide for esketamine, when compared with fluoxetine and venlafaxine. Conclusions: Apart of carefulness due to the known limitations of pharmacovigilance research conducted by using datasystem of spontaneous signals for SARs, analysis of data on points towards the need for greater attention for risk suicide following prescription of esketamine in depressed subjects. In this regard, as well as regulatory agencies recommend, patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to begin treatment, should receive a more careful monitoring during treatment.