Psychiatr. praxi 2019; 20(2): 77-81 | DOI: 10.36290/psy.2019.017

Monitoring of adverse events and safety of antidepressants

prof. MUDr. Eva Češková, CSc.^1,2,3,4, PharmDr. Kateřina Horská^2,5,6

¹ CEITEC‑MU, Brno

² Psychiatrická klinika FN Brno

³ KNP LF LF Univerzity Ostrava

Primum non nocere is one of the fundamental principles in medicine. All psychopharmaceuticals, in addition to their therapeutic effects, also have adverse events. Adverse events of individual drugs are known and included in the SPC (Summary of Product Characteristics), and it is the psychiatrist’s responsibility to inform patients about adverse events. Apart from subjective discomfort, adverse events are a major reason for treatment discontinuation. Therefore, the choice of antidepressant medication should be based particularly on individual vulnerability to adverse events. Furthermore, safety and tolerability should be monitored continuously; structured questionnaires and symptom scales should be preferred for their assessment and measurement. When an adverse reaction occurs, we can either reduce the dose, change or cease the treatment, or continue the treatment with adjunctive medication. Besides common adverse events, some serious and unexpected adverse events can occur which must be reported to the State Institute for Drug Control, the Department of Pharmacovigilance. However, the number of reports is low. The reasons may include lack of physicians’ motivation, poor availability of report outcomes, ignorance, and frequent off-label indications. Both international and national guidelines for the treatment of depressive disorder recommend off-label drugs on the basis of more recent scientific findings. Guideline updates are undoubtedly more flexible than SPC updates. Knowledge of risk factors and tolerability of adverse events in individual patients is necessary for individualized approach to the treatment.

Keywords: pharmacovigilance, antidepressants, adverse events, guidelines, individualized treatment

Published: June 1, 2019  Show citation