Pharmacoepidemiology, Volume 4, Issue 4

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...