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Epilepsy drug linked to birth defects
22 April 2017, 01:24 | Terri Saunders
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The types of birth defects attributed to the drug included spina bifida - a condition in which the spinal cord does not form properly, and can protrude through the skin - as well as defects of the heart and genital organs.
Valproate, which has been manufactured in France by Sanofi under the brand Depakine for epilepsy and Depakote and Depamide for bipolar disorders, is also believed to cause slow neurological development, ANSM said on Thursday.
But the drug can still be prescribed to pregnant women when all other forms of treatment for epilepsy fail.
The regulator itself said the figures should be "interpreted with caution", according to Sanofi's statement.
Valproate was approved as an anti-epileptic drug in France in 1967 and has become one of the most widely prescribed treatments worldwide given its effectiveness on adult patients.
The medication is responsible for "severe malformations" in 2,150 to 4,100 children in France, according to a preliminary study by French health authorities.
The drug is widely prescribed in the United Kingdom but doctors avoid giving it to pregnant women or anyone who may want children in future.
Sodium valproate is also prescribed under different brand names for people suffering from bipolar disorder.
A drug created to treat epilepsy and bipolar disorder may be responsible for 4,100 severe birth defects in babies, French health authorities have said. By the early 1980s, there were fears that the drug might be a factor in birth defects, including spina bifida, but prescription rules were only finally tightened in 2014.
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Mahmoud Zureik, ANSM's scientific director and co-author of the report, said in an interview with AFP news agency that the figure of "severe malformations" is notably high.
Women who took the same medication for bipolar disorder were twice as likely, the report said. Families of children with birth defects want to know why it took so long for this country's authorities to identify the serious risks associated with taking the drug during pregnancy.
Medsafe also includes warnings in its information for Epilim, but the current information sheet stops short of telling pregnant women not to take the drug.
"Like most medicines of this kind, Epilim may affect your developing baby if taken in the first trimester of pregnancy, as it is suspected of causing an increased risk of malformations in the exposed foetus".
A group of French families of children with birth defects, whose mothers took valproate while pregnant, have sued Sanofi, claiming it did not adequately warn about the risks.
"The number of victims is potentially huge", APESAC president Marine Martin told AFP.
Ms Martin says two of her children, a girl and a boy, suffered physical defects brought on by valproate.
Medically necessary exceptions, he added, should be rare and accompanied by "mandatory contraceptive use".
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