Thousands of children in France suffered severe birth defects after their mothers took valproate-based drugs. To date, it appears that up to 400 Irish children have also been affected.

Valproate-based drugs, primarily used to treat epilepsy, bipolar disorder and to prevent migraine headaches, were taken by up to 100,000 pregnant women in France between 1967 and 2016. According to a recent joint report by France's National Agency for the Safety of Medicines and Health Products (ANSM) and the national health insurance body, Valproate-based drugs such as Depakene, Depakote (and its derivatives) are believed to be responsible for congenital birth defects in up to 4,100 French children, who were exposed in-utero to the drugs. Valproate, branded as Epilim, has been licensed in Ireland since 1983 for use in epilepsy and bipolar disorder. Following the ANSM report, Ireland's Foetal Anti-Convulsant Syndrome Forum (FACS), an umbrella of patient and disability organisations, is again urging the government to undertake an investigation into the current and historical use of the drug in pregnant women in this country. The FACS Forum, which was established in 2013, estimates that the drug has affected at least 400 children with birth defects and developmental issues in Ireland. The Forum, which consists of The Disability Federation of Ireland, Epilepsy Ireland, OACS Ireland, Medical Research Charities Group, Migraine Association of Ireland, Shine, and the Genetic and Rare Diseases Organisation, have been working on this issue since the publication of the European Medicines Agency ruling on Sodium Valproate in 2014, which tightened restrictions on its use in women of childbearing potential. FACS Forum chairperson, Joan O’Donnell, says a review is required as a matter of urgency,

"The government urgently needs to identify the scale of the problem, to assess the often complex needs of the families affected, and to put in place appropriate pathways for the diagnosis and treatment of Fetal Anti-Convulsant Syndrome. To date, while the HPRA and HSE have taken some measures to improve awareness of the risks of valproate and to improve communication between patients and health professionals - such as producing information leaflets - the response has been unsatisfactory and there have been no efforts made to address the needs of families already affected. We would also call on the HPRA and the drug company to fulfill their promise from almost 12 months ago and immediately put warnings on the drug's outer packaging to warn women who may still not be aware of the risks."

Over the past two years, Epilepsy Ireland has conducted a number of surveys of women taking the drug to assess the levels of risk awareness and the extent of communication taking place between patients and their medical teams. While these rates are improving, the most recent survey (November 2016) found that just over half of women (56 percent) had discussed the issue with their medical team and one in five were still not aware of the new restrictions, in place since 2014. The CEO of Epilepsy Ireland, Peter Murphy, said women need to be made aware of the risks,

"While Valproate has proven to be an effective medication for preventing seizures, all women or parents of girls taking Valproate need to be aware of the risks involved. We urge them to speak to their medical team about this if they haven't already to weigh up the pros and cons, but under no circumstances should they stop taking the drug without talking to their medical team."

Dr Mahmoud Zureik, the scientific director of France's ANSM, found that the risk of major birth defects was globally four times higher in children born to a woman treated with Valproate for epilepsy, when compared to women who did not receive the drug:

"The study confirms the very important teratogenicity of Valproate. Around 3,000 major malformations are particularly high."

Dr Zureik and his colleagues found that children exposed to valproate endured abnormalities of the nervous system such as Spina Bifida, cardiovascular abnormalities, and abnormalities of their external genitalia. A total of 26 major congenital malformations were listed in the French report. The risk is twice as high in women treated with the drug for bipolar disorder,

"This difference can be explained by the fact that many women treated for bipolar disorder stopped treatment in the first trimester of pregnancy, while a good number of women treated for epilepsy only stopped treatment in the second and third trimesters."

An second French report on resultant neurodevelopmental disorders is expected later in the year. Join the conversation on Twitter @HerFamilydotie