Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-09-11-Speech-2-372-000"
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"en.20120911.32.2-372-000"2
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"This amendment to the Pharmacovigilance Directive is urgent in light of the Mediator case in France. Mediator was a medicine made by the French company Servier and licensed in a number of EU countries through national procedures (France, Portugal, Luxembourg, Greece, Italy and Spain) for the treatment of type 2 diabetes. Its main active ingredient was benfluorex, and as early as 1999, the first ADR (Adverse Reaction) reports appeared indicating concerns about possible heart valve disorders. In both the USA and the EU, similar anorectic agents – dexfenfluramine and fenfluramine – were taken off the market in the late 1990s. Despite this, Mediator was widely prescribed in Europe, and particularly in France. By 2009, when the drug was finally withdrawn from the market, an estimated five million people had been prescribed the medicine, and it was one of the top 50 most prescribed medicines in France. Evidence suggests it had been prescribed not only to diabetics, but more widely as a general appetite suppressant. Estimates of the number of deaths related to Mediator vary from 500 to 2 000."@en1
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The resource appears as object in 2 triples