A Pharmacovigilance Study of Torsade de Pointes

University of Peshawar6,670 enrolled

Overview

Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.

Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.

Study Type

OBSERVATIONAL

Enrollment

6,670

Conditions

Torsades de Pointe Caused by Drug

Interventions

Drugs, GenericDRUG

All drugs having ≥10 TdP cases reported in the FAERS database

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * TdP cases reported in the FAERS database till 31/03/2019 * Adverse event reported was including the MedDRA term: Torsade de Pointes Exclusion Criteria: * Drugs with less than 10 TdP reports

Locations (1)

Department of Pharmacy, University of Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Outcomes

Primary Outcomes

Identification of drugs associated with TdP

The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.