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[e-drug] Thousands of women took Sanofi epilepsy drug despite risk to fetuses: media

E-DRUG: Thousands of women took Sanofi epilepsy drug despite risk to fetuses: 
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REUTERS // Health News
Tue Aug 9, 2016 3:27pm EDT


Thousands of women took Sanofi epilepsy drug despite risk to fetuses: media

PARIS: More than 10,000 pregnant women in France took Sanofi's anti-epilepsy 
drug Depakine between 2007 and 2014 although the risk of fetus malformation was 
known, according to a study quoted by French satirical weekly Le Canard 

The weekly reported that the French health ministry had delayed publication of 
the study, which the ministry denied.

The ministry confirmed in a statement that a study was done by national drug 
agency ANSM and health insurance agency CNAMTS but added that it had not been 
hidden from families and that a first part of the study would be presented on 
August 24.

The ministry said it would study measures that needed to be taken and that the 
full study and an action plan based on it would be made public in September.

Sanofi said the company was not aware of the data in the study and could not 
comment on it.

A Sanofi spokeswoman told Reuters that the firm had become aware of the risk of 
fetus malformation in the 1980s and that these had been spelled out in the 
drug's documentation.

She added that from around 2003, Sanofi became aware that the drug - based on 
sodium valproate - also impacted the fetus' neurological development and could 
lead to autism or learning difficulties.

She said these potential side effects had been communicated to health 
authorities, which updated the drug's documentation in 2006. She specified that 
drug documentation needs to be approved by health authorities in France.

In a report published in February, French social affairs inspection agency IGAS 
criticized the slow response of French health authorities and Sanofi with 
regard to the risks related to Depakine and its derivatives.

IGAS estimates that between 2006 and 2014 some 425 to 450 babies suffered 
congenital birth defects or were stillborn following exposure to the drug.

It said the drug has been on the market since 1967 and that the risk of fetus 
malformation had been established since the early 1980s. Despite those risks, 
the drug continued to be prescribed because of its effectiveness against 
epileptic seizures and bipolar disorder.

In October, the Paris prosecutor launched a preliminary investigation into the 
authorization and marketing of the drug.

(Reporting by Gerard Bon and Geert De Clercq; Editing by Adrian Croft)

Lucas F.M. van der Hoeven
Heuvel 20
5101 TD Dongen
Lucas <lucas.van.der.hoeven@cbsm.nl>

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