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Has a drug causing birth defects been concealed?

By Tim Sandle     Aug 10, 2016 in Health
Paris - Concerns have arisen over an epilepsy drug and a connection to birth defects. The concerns not only relate to the drug but also to an alleged attempt by French regulators to conceal the findings.
The issue relates to a medicinal product, designed to treat epilepsy and bipolar disorder, manufactured by the French pharmaceutical company Sanofi. A charge has been made by reporters in France that the health authorities in France have attempted to conceal the findings. The French government has denied the charges. A second criticism relates to alleged attempts by the French authorities to delay publication of the study. Again this charge is denied.
According to the website Pharmaceutical Processing the study by the French authorities, that showed the birth defects, was available twelve months ago. The study was into a drug product called Depakine. The responsibility for the study rested with the French national drug agency (ANSM) together with the health insurance agency CNAMTS.
It appears, according to Le Canard Enchaine, that over 10,000 pregnant women in France took, based on medical prescriptions, Depakine between 2007 and 2014. This is despite the active ingredient of the drug (sodium valproate) carrying a risk of fetus malformation, a fact known since the 1980s according to the news agency Reuters. This is due to the drug affecting neurological development.
In addition, Sanofi have said that the drug has carried a warning to pregnant women since 2006 and the company had not seen the data from the recent study. The study by the French authorities set out to determine why the drug was prescribed despite the warnings being clear on the drug packaging.
The effects of the drug being prescribed to so many women is not one of theoretical risk. A review by the French social affairs inspection agency (IGAS) estimates that for the period 2006 to 2014 between 425 to 450 babies suffered congenital birth defects or were stillborn following exposure to the drug
Following a series of press inquiries the French authorities have confirmed that part of the results will be released on August 24 (ā€œto parents whose children have been affected by the anti-convulsion drug Depakine"), and the full study will be made available during September 2016.
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