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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group/Cohort | Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drugs, Generic | Drug | All drugs having ≥10 TdP cases reported in the FAERS database |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cases reported to the FAERS database till 31/03/2019 |
| Identification of new signals of TdP | Signal detection using disproportionality analysis | Cases reported to the FAERS database till 31/03/2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of already known drug-TdP associations | Cases reported to the FAERS database till 31/03/2019 | |
| Stratification of new signals with respect to age | Cases reported to the FAERS database till 31/03/2019 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presented with TdP treated for any disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pharmacy, University of Peshawar | Peshawar | Khyber Pakhtunkhwa | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39291052 | Derived | Ali Z, Ismail M, Rehman IU, Goh KW, Razi P, Ming LC. Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System. J Pharm Policy Pract. 2024 Sep 16;17(1):2399716. doi: 10.1080/20523211.2024.2399716. eCollection 2024. |
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| ID | Term |
|---|---|
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Stratification of new signals with respect to gender | Cases reported to the FAERS database till 31/03/2019 |
| Trends of TdP reports in FAERS database | Cases reported to the FAERS database till 31/03/2019 |
| Description of the population of patients having TdP | Cases reported to the FAERS database till 31/03/2019 |