An independent investigation on the historical prescribing of Valproate to pregnant women is urgently needed. It is now clear that hundreds of children have been born with disabilities as a direct result of the prescribing of Sodium Valproate (Epilim), a drug licensed in Ireland for the treatment of Epilepsy and bi-polar disorder. A ‘do-nothing’ approach is not acceptable in this State.
The crux of the matter is that parents were not informed of the risks or risk-reduction measures they needed to put in place, therefore they continued to be prescribed Valporate during pregnancy. I am disturbed at the Minister’s reluctance to hold an independent investigation in to the matter.
I do welcome the recent report but there are still many questions to be answered:
- We need to know IF and HOW existing cases of FACS could have been prevented.
- Whether or not appropriate and timely information was provided to healthcare professionals and patients in line with knowledge at the time.
- Whether or not appropriate decision making processes were in place concerning the treatment of women taking Valproate in line with knowledge at the time.
- Whether or not appropriate regulatory steps and communication mechanisms have been taken over time to ensure patient safety.
- How a system of redress can be established to meet the lifelong care needs of children and the impact of diagnosis on families (in order to avoid the need for legal solutions for already burdened families.
The Department of Health must sign off on funding for the established Valproate Project Group.
This State is not the only jurisdiction to be affected by the Valporate Scandal. In November last year, the French Government approved a €10m fund to meet compensation claims as a starting point. In February of this year, the British Health Secretary, Jeremy Hunt, announced a review of how Valproate concerns were handled in the past.
Valproate-related disabilities are complex, wide-ranging and individual. Obtaining a diagnosis in Ireland is difficulty and lengthy. Treatment often involves attending a multitude of unconnected and uncoordinated speciality services. Often, families have more than one child affected and, in many cases, full-time caring is required. It is therefore critical that appropriate supports are urgently put in place. I know families who desperately need therapies and treatment but cannot afford them. They sit and watch while their children regress! This is an intolerable situation for them to be left in and must stop.
These children need never have had to experience these disabilities. Their families need never have had to become life-long carers. Their lives could have been totally different
The teratogenic effects of Valproate were first reported in the 1980’s and have been widely accepted since the mid 1990s. Last year the French regulator said women taking Valproate were four times more likely to give birth to babies with malformations.
The types of birth defects attributed to the drug include spina bifida, autism and developmental problems as well as neural tube defects, malformation of limbs, digits, organs and cleft palate.
Bi-polar women taking the drug were twice as likely to give birth to children with major birth defects.
I have met with a number of these families affected through OACS Ireland (Organisation for Anti-Convulsant Sysdrome) and FACS (Foetal Anti-Convulsant Syndrome Forum) who advocate for better services and supports for families and children affected by Foetal Anti-Convulsant Syndrome.
The European Medicines Agency Introduced measures to strengthen the warnings and restrictions on the use of Valproate in women and girls. Again in February of this year following a further review they issued additional instructions aimed at further reducing the risks of the drug.