Tag: Pharmacovigilance Risk Assessment Committee (PRAC)

By Posted on Posted in Adverse Drug Reaction [ADR], New Safety Information, Thasso Post Tagged with , , , , , , , , , , , , , ,

February 14, 2016 – Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes and a number of these cases have …

SGLT2 inhibitors and diabetic ketoacidosis: PRAC makes recommendations to minimise risk to patients Read more »

By Posted on Posted in Adverse Drug Reaction [ADR], Thasso Post Tagged with , , , ,

November 7, 1014 –  This report originates from the meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) on 3-6 November 2014 at EMA. At this meeting, the PRAC took note and advised on informing about first case of PML in a patient …

First Case of Progressive Multifocal Leukoencephalopathy (PML) in a Patient Treated with Dimethyl Fumarate [Tecfidera] Read more »