Mediator® = Terminator ?

S’agit-il d’un nouveau scandale sanitaire, au même titre que la Josacine, la thalidomide, l’hormone de croissance ou encore le Distilbène ?

A écouter la presse radio, on serait tenté de répondre d’emblée par l’affirmative.

Le Mediator® (chlorhydrate de benfluorex) est un médicament autorisé depuis 1976, initialement classifié et prescrit en tant qu’hypolipidémiant. Quelques dates jalonnent son parcours : 1987, son indication a été validée en tant qu’adjuvant dans les régimes adaptés aux personnes avec des hypertriglycéridémies. 1990, une nouvelle indication en diabétologie a été validée : « adjuvant au régime adapté pour les personnes diabétiques en surcharge pondérale ». 1998, le laboratoire Servier a sollicité auprès de l’AFSSAPS une nouvelle indication thérapeutique dans le traitement du diabète de type 2 en première ligne. Cette indication n’avait pas été accordée en raison d’une insuffisance de données d’efficacité, par comparaison avec d’autres traitements antidiabétiques oraux de type 2 comme la metformine.

Une nouvelle étude menée en 2009 visant à objectiver l’efficacité du benfluorex en ajout d’un autre antidiabétique a révélé des effets indésirables dans le domaine cardio-vasculaire, ce qui a motivé la décision de l’AFSSAPS du 24 novembre 2009 aux fins de suspension de l’autorisation de mise sur le marché, dans l’attente de la décision de la Commission européenne prise en application de l’article 107 de la directive 2001/83/CE modifiée.

Qui plus est, une étude de la CNAMTS, assortie d’une étude complémentaire, rendue fin septembre et mise en ligne ce jour sur le site de l’AFSSAPS, a apporté un éclairage nouveau sur l’impact de la molécule dans la survenue de valvulopathies.

« Il est apparu que le risque de développer une valvulopathie augmente après 3 mois de traitement, explique Jean MARIMBERT, directeur général de l’AFSSAPS. Il est clair également que le risque est maximal dans les deux premières années d’utilisation et persiste deux ans après son arrêt avant de rejoindre le niveau d’une population non exposée. »

Plus encore, « Sur les 300 000 patients traités suivis sur une période de 4 ans et demi par la CNAM, il y a eu 597 hospitalisations pour insuffisance valvulaire, 64 décès dont 46 secondaires à la valvulopathie. On peut tenir pour certain qu’une centaine de décès sont dus au benfluorex sur cette période, et par extrapolation, au moins 500 au cours des trente dernières années depuis sa commercialisation » affirme le DG de l’AFSSAPS.

De son côté, le Groupe de recherche Servier souligne, dans un communiqué, que « les chiffres sont des hypothèses fondées sur des extrapolations. »

Le service juridique du laboratoire et l’assureur de ce dernier doivent sans doute se préparer, dans un avenir plus ou moins proches, à quelques procès en responsabilité médicale.

D’un point de vue plus opérationnel, on apprend qu’une mission sera confiée à l’Inspection Générale des affaires sociales (IGAS) au plus tard au 1er janvier 2011, afin qu’elle élabore des recommandations sur le développement des études post-AMM. Cette mission devra aussi proposer des dispositions nouvelles pour renforcer la coopération entre l’AFSSAPS et la CNAMTS pour avoir accès à des données de santé, nous indique le Quotidien du médecin.

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