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Medicines agency warns: Epilepsy medication causes thousands of malformations


Risk of serious birth defects from taking valproate during pregnancy
Taking valproate during pregnancy increases the risk of a child's malformation massively, according to the latest warning from the French drug safety authority ANSM. Thousands of deformities in children in France are said to be due to the use of the anti-epileptic.

The French drug agency ANSM has carried out a comprehensive epidemiological study to investigate the effects of valproate intake during pregnancy on the unborn child. The drug is mostly used for the treatment of epilepsy, but also for the therapy of bipolar disorders. In the current sub-study, the scientists mainly focused on the risk of serious malformations among young people. In the second half of 2017, another sub-study will be published that examines the effects on neurological development.

Data from almost 2 million pregnant women evaluated
Using the data from the so-called "Système National Interrégimes de l’Assurance Maladie" (SNIIRAM), the experts from the French Medicines Agency examined possible consequences of taking valproate for unborn children. The data from almost 2 million pregnant women, including 2,321 taking valproate, have been included in the current study, the ANSM said. These cover a period from 2011 to 2015 and it was also possible to relate the mothers' data to the respective offspring, reports the ANSM.

Risk of serious birth defects increased drastically
Women who took valproate to treat epilepsy in pregnancy were around four times higher than in the general population and women who took the drug for bipolar disorders around two times higher. The difference can probably be explained by the different doses of valproate in the different prescription reasons.

Bipolar Disorder Prescription
According to the ANSM, not only are lower doses prescribed for bipolar disorders, early treatment interruptions also frequently follow. In addition, sufferers with this indication would probably adhere less to the requirements for taking than with epilepsy. Despite the lower effects, however, there was also a significant increase in severe birth defects such as spina bifida (so-called open back) in prescriptions for bipolar disorders.

Can up to 4,100 birth defects in France be attributed to valproate?
The anti-epileptic valproate has been offered by the pharmaceutical company Sanofi since 1967 and since then the intake has probably caused up to 4,100 serious malformations in children in France, reports the ANSM. According to the experts, the lowest estimates assume at least 2,150 children affected. For other drugs for the treatment of epilepsy and bipolar disorders, there was no correspondingly high risk of severe congenital malformations. However, side effects also threaten here and there is an increased risk of addiction for some.

Do not prescribe valproate to patients of childbearing potential
Given the risk of birth defects in the offspring, the anti-epileptic valproate should not be prescribed to women of childbearing age and especially not to pregnant women, according to the ANSM. The application can only be considered if all other treatment approaches fail. However, the risk of birth defects should always be taken into account. (fp)

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