The Literature Alert

Identify reportable cases from published medical literature

Role: Drug Safety Scientist

Context: Your weekly literature monitoring alert has arrived. You need to review abstracts flagged by the search algorithm for potential adverse event cases involving your company's products.

Task: Evaluate each literature hit and determine appropriate action.

Step 1 of 3

The Case Report

case

Title: 'Acute Hepatotoxicity Associated with Viralex: A Case Report' Abstract: A 54-year-old female with chronic hepatitis C was started on Viralex 400mg daily. After 6 weeks of treatment, she presented with jaundice, fatigue, and elevated transaminases (ALT 1,250 U/L, AST 980 U/L). Viralex was discontinued and she was treated with supportive care. Liver function normalized over 8 weeks. The authors conclude that Viralex may cause idiosyncratic hepatotoxicity and recommend liver function monitoring. Viralex is your company's product.

Does this literature article represent a valid ICSR that must be captured?