Hepatic effects of duloxetine-III: analysis of hepatic events using external data sources

• Published in: Current drug safety Vol. 3; no. 2; p. 154
• Main Authors: Strombom, Indiana, Wernicke, Joachim F, Seeger, John, D'Souza, Deborah N, Acharya, Nayan
• Format: Journal Article
• Language: English
• Published: United Arab Emirates 01.05.2008
• Subjects: Adrenergic Uptake Inhibitors - adverse effects; Adverse Drug Reaction Reporting Systems; Chemical and Drug Induced Liver Injury; Consumer Product Safety; Cyclohexanols - adverse effects; Databases as Topic; Duloxetine Hydrochloride; Humans; Liver - drug effects; Risk Assessment; Serotonin Uptake Inhibitors - adverse effects; Thiophenes - adverse effects; United States; United States Food and Drug Administration; Venlafaxine Hydrochloride

Present results from two hepatic safety studies conducted within 20 months after duloxetine launch. Signal detection based on spontaneous reports to the FDA adverse event reporting system (AERS) and on a comparison of duloxetine and venlafaxine in the i3 Drug Safety Aperio claims database, using mea...