Abstract
Introduction:
Considering the antidepressant agomelatine (AGM) there is a discrepancy between the
widespread knowledge of the potential of AGM to cause hepatotoxic adverse drug reactions
(ADR) and the availability of corresponding published data. This impedes an adequate
assessment of the hepatotoxicity profile of AGM.
Methods:
We conducted a query of the database of a German Medical Regulatory Body (BfArM) and
analyzed spontaneous reports of hepatotoxic ADR.
Results:
We identified n=58 cases of AGM-related hepatotoxic ADR. Most frequent ADR was asymptomatic
increase of liver enzymes (79%); n=6 patients (10%) with AGM-related toxic hepatitis
were reported. Characteristics of patients: female sex (69%), age > 50 years (mean
54 years), polypharmacy (57%), and presence of cardiovascular risk factors (58.5%).
Most of the hepatotoxic ADR (90%) were reported to have improved/recovered after discontinuation
of AGM.
Discussion:
Our evaluation suggests that AGM features a potential to cause severe forms of hepatotoxicity
and emphasizes that a pre-existing liver disease is a contraindication for treatment
with AGM. Secondly, increased age, female sex and polypharmacy may be risk factors
for the development of AGM-related hepatotoxic ADR.
Key words
adverse drug reactions - antidepressants - hepatopathy - liver enzymes - melatonin
- pharmacovigilance