Investigation of the total anticholinergic load of reported anticholinergic drug-related adverse events using the Japanese adverse drug event report database: a retrospective pharmacovigilance study.

Abstract

Background: The Anticholinergic Risk Scale and Total Anticholinergic Load were developed to assess the risks associated with anticholinergic drugs. Recently, the Japan Anticholinergic Risk Scale was introduced; however, the total anticholinergic load for adverse events has not been clarified, and the criteria for risk assessment in clinical practice have not been established. In this study, we used data from the Japanese Adverse Drug Event Report (JADER) database provided by the Pharmaceuticals and Medical Devices Agency to determine the total anticholinergic load associated with reported adverse events related to anticholinergic syndrome.

Methods: Using JADER data from April 2004 to September 2023, we investigated the association between drugs included in the J-ARS and adverse events related to anticholinergic syndrome. In addition, we calculated the total anticholinergic load for each case involving a drug recorded in the JADER database and compared it with other adverse events associated with anticholinergic effects.

Results: Based on the JADER data, we observed an association between anticholinergic syndrome-related adverse events and the drugs listed in the J-ARS, confirming the feasibility of calculating the total anticholinergic drug burden for each case. In the group reporting anticholinergic syndrome-related adverse events, the mean ± standard deviation of the total anticholinergic load was 4.20 ± 3.09.

Conclusions: The mean total anticholinergic load of anticholinergic syndrome-related adverse events obtained from the JADER database in this study supports the development of a comprehensive risk assessment of anticholinergic drugs in clinical practice.