Mediator Information

On 18 April 2019, the Court announced that the Mediator trial would be held from 23 September 2019 for a period of 6 months.

Announcement of the beginning of the trial (from September 2019) by the Paris Criminal Court.

Referral order for Servier to appear before the Criminal Court.

State’s responsibility confirmed in the Mediator case.

Investigation resumes, considered incomplete by the Investigation Chamber.

Death of Doctor Jacques Servier, Olivier Laureau appointed President of Servier Group.

ANSM (National Drug Agency) indicted (previously Afssaps) for “manslaughter and unintentional injury”.

Servier indicted for “manslaughter and unintentional injury”.

The IGAS (General Inspection of Social Affairs) report is handed to the Minister of Health. Opening of two legal investigations brought against X for “deception and unlawful acquisition of an interest” and “manslaughter”. Servier proposes the setting up of a compensation fund for patients. Creation of a compensation fund managed by ONIAM (French National Office for Compensation for Medical Accidents) Indictment of Doctor Jacques Servier and 5 Servier companies for “deception and fraud”

Afssaps estimates the number of Mediator®-related deaths to be 500.

The National Pharmacovigilance Committee identifies and validates the signal of valvulopathies in patients treated with Mediator. The CAMM (Marketing Authorisation Committee) concludes that Benfluorex has a negative benefit-risk ratio. Suspension of the marketing authorisation of Mediator® and its generics by AFSSAPS.

AFSSAPS authorises the marketing of two generics of Mediator®.

The Marketing Authorisation Committee reassesses the benefit-risk ratio of Mediator® and proposes a change in the indications.

According to the National Pharmacovigilance Committee, the number of cases of pulmonary arterial hypertension does not constitute a significant signal of the toxicity of Mediator®. 2005-2009: Servier carries out a study of the efficacy and safety of Mediator® in diabetic patients.

Servier stops marketing Mediator® in Spain and in Italy for commercial and industrial reasons. Publication of a case of valvulopathy in Spain.

In response to the European health agency’s request, Servier proposes a study protocol on Mediator® to the Italian and French authorities.

First cases of aortic valvulopathy and pulmonary arterial hypertension in two patients treated with Mediator®.

Official pharmacovigilance investigation of Mediator® initiated by AFSSAPS (French Agency for the Safety of Health Products) – Opening of the European investigation.

Mediator® obtains Marketing Authorisation.