A Cohort Study of the Incidence of Serious Acute Liver Injury in Diabetic Patients Treated With Hypoglycemic Agents

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Abstract
CASE REPORTS of drug-induced liver injury frequently appear in the literature, and physicians are encouraged to report suspected cases to the manufacturers or the regulatory authorities.1 These voluntary reports serve as signals to evaluate the safety of medications after marketing approval.2 However, the limitations of spontaneous adverse drug reaction reports in postmarketing safety assessment are well recognized,3,4 and epidemiologic studies that estimate the risk of adverse events in large cohorts of drug users are needed to help interpret these reports.5