A real-world pharmacovigilance study of drug-induced QT interval
prolongation:analysis of spontaneous reports submitted to FAERS
Abstract
Objective: To identify the most commonly reported drugs associated with
QT interval prolongation in the FDA Adverse Event Reporting System
(FAERS) and evaluate their risk for QT interval prolongation. Methods:
We employed the preferred term (PT) “electrocardiogram QT prolonged”
from the Medical Dictionary for Regulatory Activities (MedDRA) 26.0 to
identify adverse drug events (ADEs) of QT interval prolongation in the
FAERS database from the period 2004-2022. Reporting odds ratio (ROR) was
performed to quantify the signals of ADEs. Results: We listed the top 40
drugs that caused QT interval prolongation. The 3 drugs with the highest
number of cases were quetiapine (1151 cases, ROR 7.62), olanzapine (754
cases, ROR 7.92), and citalopram (720 cases, ROR 13.63). The two most
frequently reported first-level Anatomical Therapeutic Chemical (ATC)
groups were the drugs for nervous system (n=19, 47.50%) and
antiinfectives for systemic use (n=7, 17.50%). More females (7,536,
51.24%) than males (5,158, 35.07%) were involved. 3720 patients
(25.29%) suffered serious clinical outcomes resulting in deaths or
life-threatening conditions. Most drugs caused QT interval prolongation
had early failure types according to the assessment of the Weibull’s
shape parameter (WSP) analysis. Conclusions: Our study offered a list of
drugs that frequently caused QT interval prolongation based on the FAERS
system, along with a description of some risk profiles for QT interval
prolongation brought on by these drugs. When prescribing these drugs in
clinical practice, we should closely monitor the occurrence of ADE for
QT interval prolongation. Keywords: QT interval prolongation,
pharmacovigilance, FAERS, data mining