RESUMO
BACKGROUND: The antidepressant escitalopram is widely prescribed for the treatment of depression. It is generally well-tolerated, and cholestasis is not mentioned in its summary of product characteristics (SmPC). We present a case of cholestatic and cytolysis liver injury due to escitalopram and a VigiBase® study. CASE SUMMARY: A 68-year-old man was admitted to our emergency unit due to clinical jaundice associated with hepatitis, pruritus and dark urine. We tested the patient for the most common etiologies of jaundice, including hemolysis, viral hepatitis, cirrhosis, carcinoma, cholangitis, cholelithiasis and intrahepatic or extrahepatic obstruction. The etiological study was negative, and an adverse drug reaction was the sole possible explanation. The patient was receiving treatment with escitalopram. Two days after its withdrawal, pruritus was resolved. Ten days after withdrawal, clinical jaundice disappeared. It took a month and three weeks after withdrawal for the patient to have normalized liver function tests. To our knowledge, this is the first reported case of cholestasis where treatment with escitalopram was the only possible cause, with a highly probable causality. In addition, we determined whether escitalopram is associated with hepatotoxicity and cholestasis by performing a disproportionality analysis. All cases of hepatobiliary disorders induced by escitalopram and reported in the World Health Organization pharmacovigilance database (VigiBase®) were analyzed to characterize this toxicity. We found that patients treated with escitalopram had an increased risk of hepatitis [odds ratio (OR) = 1.938(1.186-3.166)] and cholestasis [OR = 1.866(1.279-2.724)] [OR (95% confidence interval)]. The median duration between the introduction of escitalopram and the occurrence of acute hepatitis and/or cholestasis was ten days +/- seven days. CONCLUSION: Although extremely rare, this case report, the review of the literature and the pharmacovigilance update confirm that escitalopram can cause drug-induced hepatotoxicity and cholestasis, generally within a week after initiation. Thus, escitalopram should be withdrawn immediately if an iatrogenic cause cannot be excluded. If its responsibility is ascertained, escitalopram should be consequently contraindicated. In addition, serotoninergic antidepressants in patients with non-severe depression are ineffective and harmful. Finally, the SmPC of escitalopram should be updated to alert for this risk and give clear clinical guidelines.
