Drug Scandal Shocks France - Pharmaceutical Technology

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Drug Scandal Shocks France
Scandals regarding diabetes treatment Mediator frequently dominate French press headlines. Mediator was only withdrawn from the French market in November 2009, despite reports dating back as far as the 1990s linking similar products to valvular heart disease and pulmonary arterial hypertension. The end result is a great dissatisfaction among the French public with the French medicines regulator and the pharmaceutical industry, prompting a thorough reform of the country's pharmacovigilance system.


Pharmaceutical Technology Europe
Volume 23, Issue 3

References

1. EMA, "Questions and answers on the withdrawal of medicines containing benfluorex" (2010). http://www.ema.europa.eu

2. Inpharm, "Servier's Mediator provokes French drug safety controversy" (2010). http://www.inpharm.com

3. D.J. Heal, J. Gosden and S.L. Smith, Br. J Clin. Pharmacol., 68(6), 861–874 (2009).

4. FDA, "Questions and Answers about Withdrawal of Fenfluramine (Pondimin) and Dexfenfluramine (Redux)" (1997). http://www.fda.gov

5. Libération, "Un mal rare pour quelques kilos de trop" (2000). http://www.liberation.fr

6. J.R. Ribera et al., Rev. Esp. Cardiol., 56(2), 215–6 (2003).

7. Le Figaro, "Mediator: l'Assurance maladie mettait en garde dès 1998" (2011). http://www.lefigaro.fr

8. Le Post, "Mediator: Jacques Servier a-t-il financé Nicolas Sarkozy et l'UMP?" (2010). http://www.lepost.fr

9. Le Monde, "Mediator: Xavier Bertrand annonce une réforme de la pharmaco-vigilance" (2011). http://www.lemonde.fr


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