Servier Guilty Of ‘Involuntary Manslaughter’ in Mediator Safety Affair
French Regulator Fined For Delays In Product's Suspension
Executive Summary
The long-running Mediator saga reached a conclusion of sorts on 29 March when fines and sentences were handed out to those involved in delaying the withdrawal of a fenfluramine derivative that is thought to have caused many thousands of serious cardiac side-effects.
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A trial has begun in France to investigate the roles of the French firm Servier and the former drug regulator AFSSAPS in the Mediator scandal, where an amphetamine-like drug was kept on the market despite mounting evidence of its cardiac side-effects.
French agency head answers questions on Mediator "manslaughter"
Dominique Maraninchi, director general of the French medicines agency ANSM, has appeared before judges to answer questions relating to the agency's role in the Mediator affair, the agency has confirmed. The judges are investigating whether negligence on the part of the agency contributed to "manslaughter and involuntary injury" caused by the Servier drug between 1995 and 2009.