Drug agency warns epilepsy drugs cause thousands of malformations

Risk of serious birth defects due to valproate in pregnancy
The use of valproate during pregnancy greatly increases the risk of malformations, according to the recent warning from the French Drug Safety Authority ANSM. Thousands of malformations in children in France are due to the use of the antiepileptic.

In a comprehensive epidemiological study, the French Medicines Agency (ANSM) has studied the effects of valproate use on the unborn child during pregnancy. The drug is usually used for the treatment of epilepsy, but also for the treatment of bipolar disorders. The scientists concentrated in the current study mainly on the risk of severe malformations in offspring. In the second half of 2017, a further sub-study will be published, which examines the effects on neurological development.

By taking valproate during pregnancy, the risk of malformations in the offspring increases significantly. (Image: staras / fotolia.com)

Data from almost 2 million pregnant women evaluated
Based on the data from the so-called "National Interrégimes de l'Assurance Maladie" (SNIIRAM), the experts of the French Medicines Agency examined potential consequences of valproate intake for unborn children. Data from nearly 2 million pregnant women, including 2,321 valproate users, were included in the current study, according to the ANSM. These cover a period from 2011 to 2015 and it was also possible to correlate the data of the mothers with the respective offspring, reports the ANSM.

Risk of serious birth defects increases dramatically
Women who took valproate for the treatment of epilepsy in pregnancy, about four times higher than in the general population and in women who took the drug for bipolar disorders, about twice higher. The difference is probably explained by the different doses of valproate in the various prescription reasons.

Prescription for bipolar disorders
According to the ANSM, not only are lower dosages prescribed for bipolar disorders, but also more frequent treatment interruptions are more frequent. In addition, people with this indication would probably be less on target than in epilepsy. Despite the lower impact, however, a significant increase in severe birth defects such as spina bifida (so-called open back) was also noted in the prescriptions due to bipolar disorders.

Up to 4,100 malformations in France due to valproate?
Since 1967, the antiepileptic drug valproate has been offered by the pharmaceutical company Sanofi and since that time the ingestion has probably caused up to 4,100 severe malformations in children in France, reports the ANSM. According to the experts, the lowest estimates are based on at least 2,150 affected children. For other medicines for the treatment of epilepsy and bipolar disorders, there is no correspondingly high risk of severe congenital malformations. However, there are also side effects and there is an increased addiction risk.

Do not prescribe valproate to women of childbearing age
In view of the risk of birth defects in offspring, according to ANSM, the anti-epileptic drug valproate should not be prescribed to women of child-bearing age, and in particular, not pregnant women. Only in case of failure of all other treatment approaches, the application could be considered. However, the risk of birth defects should always be considered. (Fp)