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EU tightens drug safety law before it is even implemented

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e3455 (Published 15 May 2012) Cite this as: BMJ 2012;344:e3455
  1. Rory Watson
  1. 1Brussels

The European Union is taking the highly unusual step of amending new measures on drug safety before the legislation introducing them, agreed almost 18 months ago, has even come into force.

The move to tighten up pharmacovigilance legislation agreed in December 2010 follows the launch last year of a major drug safety inquiry in France into the type 2 diabetes treatment benfluorex (Mediator), made by the French company Servier.

Widely prescribed in Europe, especially France, the drug, which had been taken by some …

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