Meiji Pharmaceutical University

Important potential risks not reflected in Japanese drug labeling: implications for risk management plan termination

BACKGROUND: Risk management plans (RMPs) support lifecycle management of drug-related risks. In Japan, however, their use in clinical practice remains limited, and healthcare professionals often rely on the package insert for safety information. After RMP termination at re-examin...

Body Mass Index-Related Trends in Adverse Events with Enfortumab Vedotin: Analysis of a Pharmacovigilance Database and Medical Records

Abstract Background Enfortumab vedotin (EV) is an antibody–drug conjugate used to treat advanced urothelial carcinoma. Although EV therapy is effective, adverse events—particularly skin disorders—pose a challenge to optimal treatment. Previous reports suggest that body mass index...