vortioxetine and Drug-Overdose

Vortioxetine is an antidepressant recently licensed in the US and EU for the treatment of major depressive disorder. No fatalities from vortioxetine overdose have been reported, yet. Two cases of attempted suicide are described in the literature, although no toxicological analyzes were conducted. Vortioxetine concentrations found in blood and organs in a case of a probable acute lethal intoxication are reported here. A 65-year-old woman was found on the floor behind her bed with no vital signs. The woman was recently on vortioxetine 10 mg/day for major depression, anxiety, and psychotic attacks. Vortioxetine was quantified in blood, brain, liver, kidney, and lung samples by LC-MS/MS. Vortioxetine concentrations were: 1.197 ng/ml in the blood, 804 ng/g in the brain, 8.992 ng/g in the lung, 1.389 ng/g in the liver, 292 in the kidney. No other substance was found. In the case reported here, the blood concentration was approximately 35-135 times higher than the antemortem therapeutic value. Histological examination showed signs of a probable sudden cardiac death following to arrhythmia, with no evidence of myocardial infarction. The present case indicate that blood concentrations close to 1,000 ng/mL could lead to death, involving probably to a cardiac toxicity.

Topics: Aged; Chromatography, Liquid; Depressive Disorder, Major; Drug Overdose; Female; Humans; Tandem Mass Spectrometry; Vortioxetine

Vortioxetine is a new multimodal antidepressant approved by the Food and Drug Administration for the treatment of Major Depressive Disorder and recently introduced in Europe. While antidepressant properties of vortioxetine and its tolerability have been demonstrated by preclinical and clinical studies data on the safety of vortioxetine after overdose are still lacking.. A 50-year-old Caucasian man presenting a severe depressive episode that in a suicide attempt he took vortioxetine at 250 mg.. Suicide attempt by vortioxetine in a patient affected by Major Depressive Disorder.. General evaluations and gastric lavage with 2 L of water plus 50 g of activated charcoal was performed. After 12 hours of clinical stability, the patient was discharged from the emergency department and considering the suicidal ideation he was admitted to the inpatients psychiatric department.. After vortioxetine overdose the patient displayed no clinical signs or symptoms resulting from the exposure suggesting a good safety in overdose.. Overdose safety of different antidepressant drugs is a matter of great considering that overdose in individuals affected by Major Depressive Disorder frequently involves prescribed antidepressants. Previous studies showed wide variation in the relative toxicity of different antidepressant drugs with higher toxicity for tricyclic antidepressants, followed by venlafaxine bupropion and mirtazapine and lower for selective serotonin reuptake inhibitors. By now there is limited clinical trial experience regarding human overdose with vortioxetine and the maximum single dose tested was 75 mg in men associated with increased rates of nausea, dizziness, diarrhea, abdominal discomfort, generalized pruritus, somnolence, and flushing. Even if there is still limited available evidence and further investigation is needed to better understand the potential risk of vortioxetine overdose; from our case, it seems that vortioxetine overdose at 250 mg (12 times the common daily dose) showed no signs or symptoms resulting from the exposure suggesting a good safety in overdose.

Topics: Antidepressive Agents; Charcoal; Depressive Disorder, Major; Drug Overdose; Gastric Lavage; Humans; Male; Middle Aged; Piperazines; Psychiatric Status Rating Scales; Suicidal Ideation; Suicide, Attempted; Sulfides; Treatment Outcome; Vortioxetine