Can benfluorex induce congenital malformations?
Inserm U1027, service de pharmacologie, faculté de médecine, CHU de Toulouse, 37, allées Jules-Guesde, 31000 Toulouse, France. Electronic address: .Diabetes & Metabolism (Impact Factor: 3.27). 05/2012; 38(4):373-4. DOI: 10.1016/j.diabet.2012.02.013
Article: Aspect pharmaco-épidémiologique
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ABSTRACT: The present article describes the first French database of drugs prescribed and dispensed during pregnancy and the outcome of these pregnancies, named EFEMERIS (Évaluation chez la Femme Enceinte des MÉdicaments et de leurs RISques). At the present time, EFEMERIS contains anonymous data concerning around 78,000 pregnant women who gave birth to a baby between 1 July 2004 to 31 December 2012 in Haute-Garonne (South West France) and who are registered in the French health insurance service. Data sources include 1- the French health insurance database (drugs prescribed during pregnancy), 2- the mother and child protection centre database (newborn health) 3- the antenatal diagnostic centre database (medical pregnancy interruptions) and 4- medical data from the hospital (PMSI). EFEMERIS provides exact data on period of exposure to drugs, pregnancy terminations, and follow up of the babies 9 months and 2 years after birth. It is incremented each year with around 10 000 new pregnancies. Analysis of data until December 2011 shows a prevalence rate of congenital anomalies of 2.4%. Pregnant women were prescribed around 10 different reimbursed drugs during their pregnancy, the potential risk of a lot of these medications having not been evaluated during pregnancy. EFEMERIS can be used to monitor the prescription of reimbursed drugs to French pregnant women as well as to identify adverse pregnancy outcomes such as congenital malformation or effects on psychomotor development of the child. Examples of some studies already performed are given.
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