AIM: @entity99 ( @entity99 ) is often responsible for @entity879 , drug withdrawal, boxed warnings or drug non-approval. Therefore, we conducted a case-control study to determine the hepatotoxic risk of a wide range of drugs. METHODS: The Berlin Case-Control Surveillance Study FAKOS included all 51 Berlin hospitals in a hospital network. Between 2002 and 2011, 198 @entity1 with acute idiopathic @entity99 , 377 inpatient controls and 708 outpatient controls were ascertained. Case @entity1 were thoroughly validated using anamnestic, clinical, laboratory, and histological data. Drug exposure was obtained in a face-to-face interview. A possible drug aetiology was assessed in individual @entity1 by applying the updated Council for International Organizations of Medical Sciences (CIOMS) scale. Drug risks were further quantified [odds ratios (OR) with 95% confidence intervals (CI)] in a case-control design with unconditional logistic regression analysis. Drug intake in the last 28 days before index date was considered for the analysis. RESULTS: The study corroborated hepatotoxic risks for a number of drugs, including phenprocoumon (OR: 3.3, 95%CI: 1.5-6.7), @entity2643 (OR: 5.5, 95%CI: 1.3-21.2), @entity1088 (OR: 34.6, 95%CI: 2.8-824.9), and @entity29588 (OR: 40.2, 95%CI: 5.5-856.9). Increased risks were also suggested for less commonly reported substances such as angiotensin II-receptor blockers, atypical antipsychotics and for biperiden, a drug never before reported to be hepatotoxic. CONCLUSIONS: Our study identified a large number of drugs as possible causes of hepatotoxicity. The observed risk for seldom reported substances highlights the need for further postauthorisation safety studies not exclusively focussing on drugs already labelled as potentially hepatotoxic.

XXXX : results from the hospital-based Berlin Case-Control Surveillance Study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1088 :: ('MESH:D003024', 'Chemical') :: ['clozapine'] @entity2643 :: ('MESH:D000638', 'Chemical') :: ['amiodarone'] @entity879 :: ('MESH:D017114', 'Disease') :: ['acute liver failure'] @entity29588 :: ('MESH:C034161', 'Chemical') :: ['flupirtine'] @entity99 :: ('MESH:D056486', 'Disease') :: ['Drug-induced liver injury', 'hepatitis', 'DILI']
@entity99 :: (MESH:D056486,Disease) :: ['Drug-induced liver injury']
