According to our information, Depakote and Depamide will be contraindicated from July to pregnant women or women without contraception suffering from bipolar disorders.
After the Dépakine scandal, the time has come to strengthen regulations. Three products marked this health affair: sodium valproate, indicated in epilepsy, Dépakote (sodium divalproate) and Depamine (valpromide), used in the treatment of bipolar disorders. All three drugs cause severe deformities and neurodevelopmental disorders in exposed babies in utero. These effects, which have been known for some time, have not been reported in many pregnant women who have been prescribed the drugs during their pregnancy.
While the trials are preparing, with several criminal complaints and a group action – the first in France – the authorities have stepped up surveillance around this product, as well as information for patients. The boxes now contain a clear statement of the risks to exposed fetuses.
Alternatives
The ANSM (National Medicines Safety Agency) wished to go further by asking that Dépakote and Depamine no longer be prescribed to pregnant women and women of childbearing age not using effective contraception in order to avoid any risk.
In fact, several therapeutic alternatives exist for bipolarity, and could be preferred. In addition, the epidemiological study conducted by the CNAMTS on valproate showed that when they were pregnant, bipolar women often seemed to abandon their treatment.
The situation was therefore conducive to a request for a contraindication in bipolarity. According to our information, the ANSM has launched a procedure with the European Medicines Agency to restrict the indication of Depakote and Depamide. The contraindication will first be effective in France and should occur in the first half of July, the ANSM confirmed to Pwhy doctor.
On the other hand, it will not be possible to contraindicate Depakine in epilepsy, given the absence of a therapeutic alternative for certain forms of epilepsy. The drug therefore remains indicated as a last intention, after failure of all other alternatives. Caution will therefore be required when prescribing.
.