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: [email protected]

Electronic Supplementary Material

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

Group 2 – QT INTERVAL ABNORMALITIES

MedDRA description MedDRA PT WHO-ART description WHO-ART PT WHO-ART IT (all LLT (all IT included) included) 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 0503007 repolarisation abnormal Electrocardiogram U-wave abnormality $ 10055032 Electrocardiogram R on T 0503008 phenomenon 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.

2 Group 3 – VENTRICULAR FIBRILLATION/TACHYCARDIA

3A – Ventricular fibrillation OR Cardiac fibrillation

MedDRA description MedDRA PT WHO-ART description WHO-ART PT (all LLT included) (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 MedDRA WHO-ART description WHO-ART PT WHO-ART IT (all LLT included) LLT (all IT included) 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

3 Group 4 – SUDDEN CARDIAC DEATH

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

MedDRA description MedDRA PT WHO-ART description WHO-ART PT (all LLT included) (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 WHO-ART description WHO-ART PT (all LLT included) (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”