Table 4.
Summary of fatalities from the narrow SMQ search (n = 8)
| Preferred term of interest | Risk factors identified | Causality of death in relation to hydroxyzine administration | ||
|---|---|---|---|---|
| Dosage (mg/day) | Relevant medical history | Relevant concomitant drugs | ||
| ECG QT prolonged | 100–300 | Yes (Cardiovascular disorders) | Yes | Information not provided |
| ECG QT prolonged | ≤100 | Yes (Cardiovascular disorders) | Yes | Information not provided |
| ECG QT prolonged | ≤100 | Yes (Renal disorders) | Yes | Information not provided |
| TdP | Unknown | Yes (HIV infection) | Yes | Considered unrelated |
| TdP | ≤100 | Yes (Cardiovascular disorders) | Yes | Information not provided |
| TdP | >300 | Unknown | Unknown | Intentional overdosea |
| Ventricular tachycardia | Unknown | Yes (Underlying lupus erythematosus) | Yes | Considered unrelated |
| Ventricular tachycardia | Unknown | No | Yes | Information not provided |
ECG, electrocardiogram; n, refers to the number of cases; QT, QT interval is defined as the time between the beginning of the Q wave and the end of the T wave of the PQRST cardiac activity cycle; SMQ, standard MedDRA query; TdP, torsade de pointes.
a
Information relating to the overdose is limited and the intake of multiple medications cannot be excluded.