Background
Sodium Valproate, which is prescribed to control seizures under a variety of brand names including Epilim, Episenta and Epival, carries a 40% chance of causing developmental problems in the unborn child. These include autism, low IQ and learning disabilities. In addition, it carries a 10% chance of causing physical abnormalities.
In February 2016, the European Medicines Agency (EMA) decided that the information provided to patients required substantial improvement in the form of a new toolkit. Despite that, a very recent survey of female epilepsy sufferers revealed that sixty eight per cent of them had not received any materials from the toolkit.
It has also been revealed that one in six women taking the drug still do not know of the risks and twenty one per cent had not had a discussion initiated by their GP, neurologist or other healthcare professional about the issue.
Epilepsy charities and other support organisations are now calling urgently for all women of childbearing age to have an annual face-to-face consultation with a health professional before their repeat prescription is renewed.
How long have these huge risks been known?
It is now thought that since the 1970s, around 20,000 children have been harmed as a result of their mothers taking Sodium Valproate whilst pregnant. And the terrifying truth is that these risks have been known since the early 1970s.
At a public hearing of the European Medicines Agency, which is conducting a risk assessment of the drug, Catherine Cox of the Fetal Anti-Convulsant Syndrome Association said “these warnings could have and should have been given in 1974. However, there was a deliberate decision not to publish them.”
Documents from 1973 reveal that when considering whether to tell patients about the risks, it was decided that this “could give rise to fruitless anxiety”. A letter to doctors warned that “this compound has been shown to be teratogenic in animals, meaning it could harm the human foetus.” However, the then Committee on the Safety of Medicines said the warning should “not (go) on the package inserts, so that there would be no danger of patients themselves seeing it.”
Sodium Valproate Claim
The leading Sodium Valproate solicitor, David Gazzard, says “even judged by the standards of the time, this is scandalous. This is nothing short of treating people with contempt. How many lives had to be ruined before these clear and substantial risks were taken seriously?”
David is currently working with many families affected by Sodium Valproate. To speak to him informally and in confidence, feel free to call him on 01793 615011, or email him direct at david.gazzard@blbsolicitors.co.uk
