Depression is associated w/ an increased risk of suicidal thoughts, self-harm & suicide. It is a general clinical experience that the risk of suicide may increase in the early stages of recovery. Close supervision of high-risk patients should accompany drug therapy. Patients (& caregivers) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts & unusual changes in behaviour & to seek medical advice immediately if these symptoms present. Should be introduced cautiously in patients who have a history of seizure or in patients w/ unstable epilepsy. Patients should be monitored for the emergence of signs & symptoms of Serotonin Syndrome or NMS. Should be used w/ caution in patients w/ a history of mania/hypomania & should be discontinued in any patient entering a manic phase. Patients treated w/ antidepressants, including vortioxetine, may also experience feelings of aggression, anger, agitation & irritability. Patient's condition & disease status should be closely monitored. There have been reports of cutaneous bleeding abnormalities w/ the use of antidepressants w/ serotonergic effect, including vortioxetine. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. Hyponatraemia has been reported rarely w/ the use of SSRIs/SNRIs. Mydriasis has been reported in association w/ use of antidepressants, including vortioxetine. This mydriatic effect has the potential to narrow the eye angle resulting in increased IOP & angle-closure glaucoma. Caution should be exercised for patients w/ renal or hepatic impairment. Should not be used in childn & adolescents <18 yr.
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