Surveillance of drugs that most frequently induce acute kidney injury: A pharmacovigilance approach

Abstract

A comprehensive study using a pharmacovigilance database enabled us to identify the drugs that most frequently induce AKI, raising physicians' awareness of the drugs in use for patients with potentially decreased renal function.

Association of Stevens‐Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs in pediatric patients: Subgroup analysis based on a Japanese spontaneous database

“…The present study used data from the public release of PMDA’s JADER database as a large spontaneous reporting database, from which adverse event reports voluntarily submitted to the PMDA between April 2004 and January 2017 are freely available. The data structure of the JADER consists of four datasets: patient demographic information (DEMO), drug information (DRUG), adverse events (REAC) and medical history (HISTO).…”

“…We compiled a cross‐tabulation table based on two classifications: the presence or absence of the adverse event, and the presence or absence of the suspected medicine. Then, we calculated the ROR as reported previously . The ROR is the rate of reporting a specific adverse event caused by a particular drug divided by the rate of the same adverse event caused by all other drugs present in the database.…”

“…Therefore, unexpected and serious adverse events are sometimes encountered in post‐marketing reports, so pharmacovigilance activities are important to reveal them. In April 2004, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) established a spontaneous reporting system, the Japanese Adverse Drug Event Report (JADER) database, a unitized large‐scale database for pharmacovigilance . The objective of this study was to analyse the characteristics of SJS and TEN associated with AEDs in pediatric patients using a spontaneously reported adverse drug events database in Japan.…”

“…The present study used data from the public release of PMDA's JADER database as a large spontaneous reporting database, 11,[13][14][15] from which adverse event reports voluntarily submitted to the PMDA between April 2004 and January 2017 are freely available.…”

“…Then, we calculated the ROR as reported previously. 11,[13][14][15] The ROR is the rate of reporting a database. In addition, the ROR was frequently used in spontaneous reporting databases as an index of the relative risk of drug-associated adverse events.…”