Epilim Sodium Valproate in pregnancy another health catastrophe.
Epilim Sodium Valproate in pregnancy another health catastrophe. Every pregnant woman who was prescribed a Sodium Valproate derivative drug should have been told the risks of potential foetal damage arising from Sodium Valproate which is a drug that has been approved for treatment of bi-polar disorder, seizure disorders, migraine headaches, epilepsy etc.
Attention now has focused upon the epilepsy treatment product Epilim used for the treatment of epilepsy. It is most commonly known as Epilim / Dapakine / Depakote / Depamide. It is believed that it has caused severe birth defects in up to 4,000 French children according to the French Health Authorities. Also in the United Kingdom, it is believed that 48,000 pregnant women who received the drug tragically resulted in 19,200 children being born with either birth defects and/or developmental problems.
The full extent of the health catastrophe that has occurred in relation to unborn children being injured in utero and sustaining development delay or birth defects, is yet to be ascertained in this jurisdiction. Estimates have been calculated that 1,600 pregnant mothers received the Epilim product resulting in an overall conclusion that 400 babies were injured in utero with either development delay or birth defect consequences in Ireland.
Many of these children will require lifelong care and have lost the expectation of a quality of life that each person cherishes and deserves.
Why such a situation occurred where it was realised in documents as early as 1973 that in laboratory studies relating to Sodium Valproate that teratogenic effects could occur in animals, yet the product was still released into the international market on the basis that such detail if disclosed “could give rise to fruitless anxiety” is a question that must urgently be answered.
Sodium valproate or its derivatives were licenced in the UK in 1973 and in the Irish jurisdiction in 1983. Why it has taken more than 40 years to ascertain the true extent of this health catastrophe in Europe and indeed in Ireland, in excess of 34 years, is a matter of significant and serious concern. If the drug had not been licensed or alternative treatments prescribed for epilepsy where such treatment had been effective, then many children would have been born in a healthy condition and matured to live full and complete lives. For such unborn children to be deprived of that opportunity is unconscionable in the context of a risk that one must question was appreciated or ought to have been appreciated where a “Dear Doctor” letter warned health professionals:-
“This compound has been shown to be teratogenetic in animals, and could harm the human foetus”.
Applying in medical terms a precautionary approach to the use of drugs, such concerns ought to have alerted Regulators and other professionals who were aware of this detail, of the risks of the prescription of such a drug to a pregnant mother.
Considering the range of Sodium Valproate derivative drugs that may have been utilised during pregnancy, the full extent of this tragic and avoidable health catastrophe remains unascertained. The failure on the part of the Irish State to maintain a central database of prescription medications utilised on an individual basis means that effective audit, tracing, and ascertainment of persons injured as a consequence of this drug is now more difficult to ascertain. Also if such a system existed, then it ought to have been capable of being utilised for pharmacovigilance and for pharmacological audit purposes to ascertain adverse events or consequences from each drug being prescribed thereby allowing the Regulator to appreciate much earlier, the risk associated with Sodium Valproate enabling earlier withdrawal and recall of such drug.
A serious issue exists in relation to the inadequacies of Patient Information Leaflets and warnings which ought to be assessed against the state if knowledge of the risks during pregnancy of utilising Sodium Valproate.
For a period in excess of 20 years, Malcomson Law have represented numerous Claimants in various group or multiparty actions, both in Ireland and other jurisdictions. These actions related to defective products including blood products, pharmaceutical products, and medical devices. In that regard, we are very familiar with the principles that are required for the purposes of advancing such defective product litigation.
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RTE Website – www.rte.ie/news/2017/0926/907629-epilepsy-valproate-european-medicine/ which is the European Medicines Agency in the overuse of epilepsy drug for pregnancy women.
RTE Website – www.rte.ie/player/ie/show/prime-time-extras-30003379/10781758/ Epilepsy Medication Controversy | Prime Time.
Epilepsy Ireland – www.epilepsy.ie/index.cfm?spKey=news.epilepsy&spId
The Guardian (Article 26th September 2017) –
www.theguardian.com/society/2017/sep/26/sodium-valproate-birth-defect-risks-known-40-years-ago-campaigners – Birth Defect Risks of Sodium Valproate known 40 years ago
The Mail Online (13th December 2016) – http://www.dailymail.co.uk/wires/ap/article-4029220/Families-bring-class-action-against-French-drug-maker-Sanofi.html – Families take Class Action against French Drugmakers, Sanofi