France has decided to ban use of sodium valproate among women who are of child bearing age group and not on any efficient contraception. At the moment this applies only for those with bipolar disorder. They wanted to do the same for epilepsy as well, however, lack of alternatives have stopped France from banning it for this indication as well. It is contra indicated in pregnancy for both epilepsy and bipolar disorder in Australia and New Zealand. Most countries have strict guidelines on prescribing valproate in women of child bearing age group. It is expected that EU would soon ban valproate prescription for women of childbearing age group following French example.
Valproate is the most teratogenic drug around. Up to 40% of pre school children exposed to valproate in utero have developmental problems. Risk of autism is five times in this group. Risk of malformations is 12% compared with 2-3% in general public.
Valproate victims in France is preparing a class action suit against the pharma giant Sanofi.Sanofi is refusing to acknowledge its responsibility or the causation. It is expected that 30,000 children would have to be compensated and the total bill would be more than 400 million euros.
In countries where guidelines are not strictly followed or prescriptions monitored, many women could be exposed to these serious risks. Prescribers need to be extra vigilant on these risks and consider alternative medications.
Casassus B. Lancet. 2017 Jul 15;390(10091):217. doi: 10.1016/S0140-6736(17)31866-4. No abstract available.