Antipsychotics and torsadogenic risk: signals emerging from the US FDA Adverse Event Reporting System database.

ABSTRACT:

Background

Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden.

Objective

As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US FDA Adverse Event Reporting System (FAERS) database to detect signals of torsadogenicity for antipsychotics (APs).

Methods

Four groups of events in decreasing order of drug-attributable risk were identified: (1) TdP, (2) QT-interval abnormalities, (3) ventricular fibrillation/tachycardia, and (4) sudden cardiac death. The reporting odds ratio (ROR) with 95 % confidence interval (CI) was calculated through a cumulative analysis from group 1 to 4. For groups 1+2, ROR was adjusted for age, gender, and concomitant drugs (e.g.

SUBMITTER: Poluzzi E 

PROVIDER: S-EPMC3664739 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature