DIQTA 1.0: Drug-Induced QT Prolongation Atlas

DESVENLAFAXINE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIQT concern

Severity Score:2.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

OVERDOSAGE
Human Experience with Overdosage
In postmarketing experience, overdose with venlafaxine (the parent drug of desvenlafaxine) has occurred predominantly in combination with alcohol and/or other drugs. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, seizures, and vomiting. Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, and death have been reported.
CLINICAL PHARMACOLOGY
Pharmacodynamics
ECG changes
Electrocardiograms were obtained from 1,492 desvenlafaxine treated patients with major depressive disorder and 984 placebo-treated patients in clinical studies lasting up to 8 weeks. No clinically relevant differences were observed between desvenlafaxine treated and placebo-treated patients for QT, QTc, PR, and QRS intervals. In a thorough QTc study with prospectively determined criteria, desvenlafaxine did not cause QT prolongation. No difference was observed between placebo and desvenlafaxine treatments for the QRS interval.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24079

Other ADRs

49362

38332225

Odds Ratio = 0.42

Drug Property Information

ATC Code(s):

N06AX23 - desvenlafaxine

N06AX - Other antidepressants
N06A - ANTIDEPRESSANTS
N06 - PSYCHOANALEPTICS
N - NERVOUS SYSTEM

Active Ingredient:DESVENLAFAXINE SUCCINATE

Active Ingredient UNII:ZB22ENF0XR

Drugbank ID:DB06700

PubChem Compound:125017

CTD ID: D000069468

PharmGKB:PA165958374

CAS Number:93413-62-8

Dosage Form(s):tablet, extended release

Route(s) Of Administrator:oral

Daily Dose:

50.0 mg/day N06AX23

Chemical Structure:

SMILE Code:
CN(C)CC(C1=CC=C(O)C=C1)C1(O)CCCCC1

Reference

1: Levomilnacipran for the treatment of major depressive disorder: a review.

[Asnis Gregory M,Henderson Margaret A]
Neuropsychiatr Dis Treat,2015 Jan 9;11:125-35. PMID: 25657584

2: Risk of QT/QTc prolongation among newer non-SSRI antidepressants.

[Jasiak Natalia M,Bostwick Jolene R]
Ann Pharmacother,2014 Dec;48(12):1620-8. PMID: 25204465

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