Antipsychotics and Torsadogenic Risk: Signals Emerging from the FDA Adverse Event Reporting

Drug Safety

Antipsychotics And Torsadogenic Risk: Signals Emerging From The FDA Adverse Event Reporting System Database

Elisabetta Poluzzi, Emanuel Raschi, Ariola Koci, Ugo Moretti, Edoardo Spina, Elijah R Behr, Miriam Sturkenboom, Fabrizio De Ponti

Correspondence:

Electronic Supplementary Material

Table S2. Outcome Codification

List of the codes used for the search strategy according to both for MedDRA and WHO-ART terminologies. The analysis of the FDA_AERS requires only MedDRA terminology. The list was finally adopted as of 7-02-2011.

Group 1 – TORSADE DE POINTES

MedDRA description / MedDRA PT
(all LLT included) / WHO-ART description / WHO-ART PT
(all IT included)
Torsades de pointes # / 10044066 / Torsade de pointes / 1431

Group 2 – QT INTERVAL ABNORMALITIES

MedDRA description / MedDRA PT
(all LLT included) / WHO-ART description / WHO-ART PT
(all IT included) / WHO-ART IT
Electrocardiogram QT prolonged # / 10014387 / QT prolonged / 1361
Long QT syndrome # / 10024803 / ECG QT interval abnormal / 0503010
Long QT syndrome congenital # / 10057926 / QT syndrome congenital / 1165002
Electrocardiogram QT interval abnormal / 10063748 / ECG U wave abnormality / 0503009
Electrocardiogram QT shortened / 10014388 / Electrocardiogram repolarisation abnormal / 0503007
Electrocardiogram U-wave abnormality $ / 10055032 / Electrocardiogram R on T phenomenon / 0503008
Electrocardiogram U-wave biphasic $ / 10055068
Electrocardiogram repolarization abnormality $ / 10052464
Electrocardiogram R on T phenomenon / 10048883

Note that WHO-ART terminology does not distinguish between QT abnormalities and QT shortening.

Group 3 – VENTRICULAR FIBRILLATION/TACHYCARDIA

3A – Ventricular fibrillation OR Cardiac fibrillation

MedDRA description / MedDRA PT
(all LLT included) / WHO-ART description / WHO-ART PT
(all IT included)
Ventricular fibrillation $ / 10047290 / fibrillation ventricular / 0440
Ventricular flutter $ / 10047294 / fibrillation cardiac / 0442
Cardiac fibrillation $ / 10061592

3B and 3C – Ventricular tachycardia OR Ventricular arrhythmia OR tachyarrhythmia

MedDRA description / MedDRA PT
(all LLT included) / MedDRA LLT / WHO-ART description / WHO-ART PT
(all IT included) / WHO-ART IT
Ventricular tachicardia # / 10047302 / Tachycardia ventricular / 0230
Ventricular tachyarrhythmia / 10065341 / Arrhythmia ventricular / 0435
Ventricular arrhythmia $ / 10047281 / Tachycardia / 0224
Ventricular extrasystoles / 10047289 / Extrasystoles / 0438
Tachycardia / 10043071 / Tachyarrhythmia / 0433002
Tachycardia Foetal / 10043074
Tachycardia Paroxysmal / 10043079
Tachyarrhythmia / 10049447
Neonatal tachycardia / 10049775
Extrasystoles / 10015856

Group 4 – SUDDEN CARDIAC DEATH

4A – Sudden cardiac death OR cardiac arrest OR sudden (unexpected) death

MedDRA description / MedDRA PT
(all LLT included) / WHO-ART description / WHO-ART PT
(all IT included)
Sudden cardiac death $ / 10049418 / cardiac arrest / 0437
Cardiac arrest $ / 10007515 / cardiac arrest neonatal / 0834
Cardiac arrest neonatal / 10007516 / sudden death / 1134
Cardio-respiratory arrest $ / 10007617 / sudden infant death syndrome / 0981
Cardio-respiratory arrest neonatal / 10007618
Ventricular asystole / 10047284
Sudden death $ / 10042434
Sudden infant death syndrome / 10042440

4B – Syncope

MedDRA description / MedDRA PT
(all LLT included) / WHO-ART description / WHO-ART PT
(all IT included)
Adams-Stokes syndrome / 10001115 / Syncope / 0223
Syncope $ / 10042772
Drop attacks / 10013643
Loss of consciousness $ / 10024855

# included in the narrow search strategy of the SMQ “TdP/QT prolongation”

$ included in the broad search strategy of the SMQ “TdP/QT prolongation”