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Background: Furosemide is one of the most frequently prescribed loop diuretics for cardiovascular conditions, particularly in the management of volume overload and acute elevations in blood pressure. However, detailed real-world data describing its u...

Background: Preterm prelabour rupture of membranes (PPROM) is the spontaneous rupture of fetal membranes prior to 37 weeks of pregnancy. Latency antibiotics, including macrolides with or without group B streptococcus (GBS)-covering antibiotics, are r...

Background: Acalabrutinib is a selective Bruton tyrosine kinase inhibitor widely used for chronic lymphocytic leukemia and mantle cell lymphoma. Real-world safety evidence from Latin America remains limited, which restricts local benchmarking and pha...

Background: Pharmacovigilance is a critical component of patient safety, particularly among older adults with chronic diseases who are frequently exposed to polypharmacy. In Kosovo, adverse drug reactions (ADRs) reported by patients remain insufficie...

Background/Objectives: To evaluate the incidence, characteristics, and clinical outcomes of intraocular inflammation (IOI) associated with intravitreal faricimab (IVF) in patients with neovascular age-related macular degeneration (nAMD) and diabetic...

Background: According to the literature, adverse drug reactions (ADRs) account for 5–10% of hospital admissions and affect 25–30% of hospitalized patients, but no data are available for Gabon. Objectives: To estimate the incidence of ADRs...

Probiotics and microbiome-based therapeutics are increasingly used to prevent antibiotic-associated diarrhea (AAD) and support gut microbiota health across children, adults, and elderly populations. Evidence synthesized in this narrative review from...

Background/Objectives: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are widely used in type 2 diabetes mellitus for glycemic control and cardiovascular–renal protection, but adverse effects such as acute kidney injury (AKI), urinary tract...

Objective: The objective of this study was to determine whether Non-Hispanic Black (NHB) or Non-Hispanic White (NHW) Alzheimer dementia patients with neuropsychiatric symptoms (ADNPS) differ regarding treatment with second-generation antipsychotics (...

Objectives: Real-world evidence that supports decision-making must meet numerous criteria, including validated identification of clinical outcomes. This study aimed to develop and validate a method for identifying new cases of myocardial infarction (...

Objectives: To evaluate reports of diabetic ketoacidosis (DKA) associated with antipsychotic drug (APD) use submitted to the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS). Methods: A retrospective pharmacovigilance...

Pharmacovigilance approaches have conventionally focused on the use of epidemiological data to detect emergent adverse drug reactions (ADRs). Recent advances in the use and availability of real-world data have expanded opportunities to detect ADR sig...

Background/Objectives: Human immunodeficiency virus (HIV) continues to be a global public health concern. Several antiretroviral drugs have been approved for the treatment, post-exposure, and pre-exposure prophylaxis of HIV. Darunavir (DRV) is a prot...

Background: Medication safety in pregnancy, puerperium, and perinatal periods is underexplored because these populations are excluded from clinical trials. EudraVigilance offers post-marketing evidence, but disproportionality analyses focus on isolat...

Introduction: Acute iron poisoning is a potentially life-threatening condition that primarily affects the gastrointestinal, hepatic and cardiovascular systems. While it most often occurs accidentally in children, intentional overdoses in adolescents...

Herbal medicinal products are increasingly used alongside conventional medicines, raising the risk of potential interactions such as pharmacodynamic drug–herb interactions (PD-DHIs) that can cause serious adverse drug reactions (ADRs). This rev...

Immunocompromised outpatients, including people living with HIV/AIDS (PLWH), diabetes, cancer, and organ transplant recipients, are at high risk of antimicrobial resistance (AMR) due to their weakened immune systems and use of immunosuppressive thera...

Background: Adherence to tyrosine kinase inhibitors (TKIs), the first-line treatment for renal cell carcinoma (RCC), is critical to ensure intended treatment outcomes. However, 75% of patients with RCC have persistency gaps (>7 days) within the fi...

Background: While adverse drug events (ADEs) are a major public health concern, data on the occurrence of lethal or fatal ADEs in Japan are limited. Therefore, this study aimed to elucidate the characteristics and reporting trends of lethal or fatal...

Background/Objectives: The aim of this study was to determine the suspected adverse drug reaction (ADR) profile of leukotriene receptor antagonists (LTRAs; montelukast and zafirlukast) relative to first-line asthma medications such as short-acting be...

Background: During the COVID-19 pandemic, analgesic use increased significantly, primarily due to self-medication for symptom relief. In Brazil, metamizole (dipyrone) is widely used despite international restrictions, highlighting the importance of e...

Background/objectives: In 9/2020, the United States Food and Drug Administration )FDA( posted a black box warning for all benzodiazepines, addressing their association with serious risks of abuse, addiction, physical dependence, and withdrawal reacti...

Proton pump inhibitors (PPIs) are widely prescribed medications primarily used to treat gastroesophageal reflux disease, peptic ulcer disease, and upper gastrointestinal bleeding. Despite clear therapeutic benefits in appropriate contexts, widespread...

Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly encompassed under nonalcoholic fatty liver disease (NAFLD), is a growing global health burden associated with progression to cirrhosis and hepatocellular carcino...

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Objectives: This study aimed to assess the concordance between depression and anxiety case definitions derived from algorithms based on medico-administrative data and structured interviews aligned with the fourth edition of the Diagnostic and Statist...

Background: Opioid Use Disorder (OUD) has claimed the lives of many Americans, with rates of overdose steadily rising over the past decade. Despite having highly effective medications to treat this condition, many providers still hesitate to prescrib...

Background: The validated Screening Tool of Older People’s Prescriptions (STOPP) identifies potentially inappropriate prescribing (PIP)—treatments where potential risk outweighs potential benefit. STOPP is particularly important for peopl...

Background: Incretin mimetics, including glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonist) and dipeptidyl peptidase-4 (DPP-4) inhibitors, have been increasingly utilized for glycemic control in patients with type 2 diabetes (T2D). St...

Objective: The aim of this study was to investigate a possible relationship between the time to onset (TTO) of adverse events following immunization (AEFIs) and recall bias and to compare it between AEFIs of COVID-19 vaccines reported though the spon...

Background/Objectives: Controversy exists over the use of passive reporting systems, especially the Vaccine Adverse Event Reporting System, in risk assessment. One limitation of these systems is that adverse event (AE) reporting rates cannot be calcu...

Background/Objectives: Direct oral anticoagulants (DOACs), when compared to the Vitamin K antagonist (VKA) warfarin, exhibit greater safety and effectiveness. However, DOACs may still have potential drug–drug interactions that result in major b...

Background/Objectives: Despite an improved knowledgebase, effective intervention, and guidelines, many patients with depression do not receive adequate treatment and treatment discontinuation and non-response are common. It was intended to explore th...

Background/Objectives: This systematic review aimed to identify a comprehensive list of potential opioid-related indicators from the published literature to assess prescribing safety in any setting. Methods: Studies that reported prescribing indicato...

Background/Objectivses: Antibiotic consumption patterns in remote urban areas of the Amazon region are poorly understood. This study aimed to analyze antibiotic use in the adult population of Coari, a municipality in Amazonas, Brazil. Methods: A cros...

Background/Objectives: Functional dyspepsia is associated with abdominal pain and nausea, which leads to reduced quality of life, loss of productivity, and economic loss for patients. Itopride hydrochloride (itopride) stimulates the gastrointestinal...

Background: Immuno-oncology has transformed cancer treatment, with immune checkpoint inhibitors (ICIs) like pembrolizumab playing a key role. While highly effective, these therapies can also cause immune-related adverse events. This study examines th...

Doxycycline is a semi-synthetic antibiotic in the tetracycline family. The three common subtypes of tetracyclines include naturally occurring, semi-synthetic, and new agents. Each subtype shares specific commonalities but is substantially different i...

Background: Sodium–glucose cotransporter-2 inhibitors (SGLT2Is) have demonstrated effects beyond glucose-lowering, leading to their approval for treating chronic heart failure (HF) in Japan. This study examines prescription trends for SGLT2Is i...

Background/Objectives: Several drugs used to treat prostate cancer have been reported to cause cardiovascular adverse events, and this study sought to identify the real-world risk. Methods: This study utilized real-world data from the FAERS to analyz...

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have emerged as a potent therapeutic option for the management of obesity, demonstrating exceptional efficacy in several large-scale clinical trials. Despite their promising therapeutic outcomes,...

Background: Antibiotic resistance represents a growing concern. A new strategy developed to treat severe infections is represented by ceftazidime/avibactam (CZA/AVI). Despite the promising activities against more pathogens, continuous monitoring is r...

The state of knowledge regarding the teratogenic effects of maternal use of medications during pregnancy is constantly evolving and is often uncertain. Timely access to high-quality information may reduce prolonged harmful exposures, decrease the num...

(1) Background: Although Sri Lanka is a developing country and boasts of having a well-established healthcare system along with good healthcare indices, we are still lagging in certain aspects of healthcare. One such aspect is the deficiencies in gui...

Dalbavancin, a semi-synthetic lipoglycopeptide with an extended half-life that allows for weekly dosing, is currently approved for the treatment of bacterial skin and soft tissue infections caused by susceptible gram-positive organisms. This case rep...

Background: Antibiotic resistance presents a global challenge. Community awareness of antibiotic use has not been studied extensively in Saudi Arabia. This study aimed to assess public awareness of the appropriate use and indications of antibiotics i...

Background: Despite widespread consensus on the need to reduce benzodiazepine (BZD) use in older adults, prescription rates in the U.S. have paradoxically increased over the past few decades. Objective: We examined (1) the characteristics of the BZD...

Ventricular tachycardia poses a significant therapeutic challenge. It can manifest over a spectrum from minimal palpitation symptoms to sudden cardiac death. This makes large-scale trials on the treatment of ventricular tachycardia difficult to perfo...

The future directions in leveraging real-world evidence (RWE) and real-world data (RWD) in the field of lymphoma, as compared to traditional experimental clinical trials, are poised to significantly impact research methodologies, treatment strategies...

Aims: The aim of this study was to explore the suspected adverse drug reaction (ADR) data of five licensed statins in the UK: atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin. A secondary aim was to determine if there are any ass...