Sodium valproate (Depakote, Depamide) can no longer be prescribed to bipolar women of childbearing age if they do not have contraception.
Sodium valproate is now contraindicated in the management of bipolar disorder in women. Why Doctor It had been announced a few days ago, the National Agency for Drug Safety has just officially confirmed it. As of July 7, Dépakote, Dépamide and their generics can no longer be prescribed to patients who do not have effective contraception.
Like Depakine, indicated in epilepsy, these drugs are at the heart of an upcoming legal battle. Despite the known risks of birth defects and neurodevelopmental disorders, a significant number of women have become pregnant with sodium valproate.
Alternatives exist
According to a study carried out by the ANSM, “a greater number of women of childbearing age are treated with (valproate) in bipolar disorder than in epilepsy”. If the former interrupt treatment more often during pregnancy, there are still too many.
In 2014 alone, just over 300 bipolar patients became pregnant while still taking sodium valproate. The danger was however identified. The risk of developmental or behavioral disorders is 30-40% in the context of exposure in utero. In more than 10% of cases, a congenital malformation occurs.
This stubbornness is all the more damaging as several therapeutic alternatives exist in this disorder, and could be preferred. Especially since, according to an epidemiological study conducted by Health Insurance, it has been shown that when they were pregnant, bipolar women often seemed to abandon their treatment.
A pregnancy test
The ANSM has therefore drawn the consequences of this lack of precaution. The information documents and the care agreement form are evolving. From now on, a negative pregnancy test will be required at the start of treatment and regularly during follow-up.
But the precedents of Curacne (against acne) and Soriatane (psoriasis) do not augur well for a satisfactory reaction. These two drugs are subject to strict prescription conditions… which are not respected by healthcare professionals and patients.
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.
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