OACS In Ireland - A Result:

22-11-2014 | Patient groups welcome landmark EMA valproate ruling

Patient groups, including Epilepsy Ireland, who have come together to form the FACS Forum Ireland have welcomed the European Medicines Agency decision yesterday on the need for better warnings on the side effects to expectant mothers of drugs that contain valproate.


Disability Federation Ireland (DFI), Genetic and Rare Diseases Organisation (GRDO), Medical Research Charities Group (MRCG),Organisation for Anti-Convulsant Syndromes Ireland (OACS in Ireland) as well as Epilepsy Ireland are campaigning for better warnings and information from the Department of Health about the drug, which is widely used in the treatment of epilepsy and in bi-polar disorders.

FACS Forum Ireland welcomes the landmark decision which puts strict curbs on the use of valproates by expectant mothers.


Concerns relating to Anti Epilepsy Drugs (AEDs) and Fetal Anti Convulsant Syndrome (FACS) have been growing steadily in recent years in many countries in the European Union and worldwide. FACS can be caused when a mother takes AEDs during pregnancy. The risk of disability varies according to the specific drug taken. Recent studies highlighted by the European Medicines Agency have shown a risk of developmental problems of up to 30 to 40% in pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.


In addition, data show that children exposed to valproate in the womb are at an approximately 11% risk of malformations at birth (such as neural tube defects and cleft palate) compared to a 2 to 3% risk for children in the general population. Available data also show that children exposed to valproate in the womb are at increased risk of autistic spectrum disorder (around 3 times higher than in the general population) and childhood autism (5 times higher than in the general population). There is also limited data suggesting that children exposed to valproate in the womb may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).


"It is important to emphasise that girls/women should not abruptly stop or make any changes to medication without the advice and supervision of their specialist or GP" said Peter Murphy of Epilepsy Ireland. "The danger from uncontrolled seizures to both mother and baby is a serious one in pregnancy. If you have any questions about your treatment, speak to your doctor or pharmacist straight away".


It should be noted that AEDs are also used to treat various non-epilepsy central nervous system.

Thanks to the work of a small number of parents in Ireland, in particular Ms. Karen Keely who has two sons with FACS, the impact of some AEDs during pregnancy is now finally being put in the spotlight in Ireland. Karen Keely said "I am delighted with this result. I only hope that the Department of Health will take notice and act fast to prevent any more children being born with this condition".


Philip Watt from FACS Forum Ireland called on the Department of Health "to give an urgent, considered response to prevent more children being born with the severe physical and developmental disabilities associated with FACS and to ensure adequate support is provided for those already with the condition. We are asking for a Task Force to be established that would include patient groups.


"The first priority must be to ensure no more mothers and their babies are impacted by FACS. In this context the Department of Health must ensure that accurate adequate warnings are distributed as quickly as possible. The FACS Forum met with the HPRA (Formerly Irish Medicines Board) recently and we were given assurances that this would happen as quickly as possible. We very much welcome this commitment."


The FACS Forum acknowledge that there are some warnings that already exists about the side effects of drugs containing valproate in Ireland but the EMA warning clearly shows these are inadequate.


Joan O'Donnell from DFI added that the FACS Forum members "are advocating that young people and adults with FACS and their families are sufficiently supported to deal with the wide range of severe problems that are associated with this condition."

Article taken from the Epilepsy Ireland Wesbite

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