Olaparib-related hepatotoxicity

Excerpt

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended updating product information for olaparib (Lynparza) to add the risk of hepatotoxicity, including hepatobiliary disorders, drug-induced liver injury (DILI) and increased transaminase levels, reports WHO.This follows a PRAC review of available evidence from EudraVigilance and other sources.Healthcare professionals are advised that if a patient experiences signs or symptoms suggestive of hepatotoxicity, prompt clinical evaluation of the patient and measurement of liver function tests should be performed.If DILI is suspected, olaparib treatment should be interrupted. In cases of severe DILI, treatment discontinuation should be considered. …