Epilim Inquiry – where are we now?
Posted in [Blog] on Tuesday, September 28th, 2021
Foetal Anti-Convulsant Syndrome (FACS) is an umbrella term for conditions that affect some babies exposed to anti-epileptic drugs (AED’s) in the womb which can result in congenital malformations and developmental disorders. Research suggests Sodium Valproate is one of the most teratogenic of these AED’s and was licensed in Ireland for treating epilepsy and bipolar disorder. It is also sometimes used for treating migraines. The drug was first licensed here in 1975 under the brand name Epilim. Evidence has emerged over the last 40 years or more that Valproate can cause physical and neurodevelopmental effects in children if taken by mothers during pregnancy. This group of features is currently termed as ‘Foetal Valproate Spectrum Disorder’ (FVSD).
The May 2018 Oireachtas Report on FACS by the Joint Committee on Health stated that since Sodium Valproate’s availability in Ireland in the 1970’s product information to doctors has warned of the risks of birth defects when taking Epilim during pregnancy. In spite of this warning, adequate information was not disseminated to users of Epilim. As a result, the Report found there have been numerous cases of FACS in Ireland. The Report noted that individuals with FACS were not affected by chance but by the failure to adequately inform and counsel women who were prescribed Valproate medicines. The Report also stated that further examination is required to examine liability and that the State has the responsibility to assist all those affected by FACS.
In the UK, the Cumberlege Review published in July 2020 found that since 1972 there was evidence that Valproate can cause physical and neurodevelopmental effects in children if taken by mothers during pregnancy. The Review was critical of the UK ‘system’ including manufacturers, regulators, clinicians and policy makers which ultimately failed to have adequate regard for patient safety for example by not identifying risks or acting on known risks in a timely manner.
In November 2020, the Minister for Health announced an Inquiry into the historical licensing and use of Epilim. Since that time there has been little progress made in relation to when the Inquiry is to occur and its terms of reference leaving affected families in limbo. Mothers of children affected by FVSD have been waiting for years to get answers as to why they were not warned of the risks of taking the medication while pregnant. A number of observers have noted similarities between what happened here and the Thalidomide scandal. In order to ensure the Inquiry is meaningful, the focus needs to be centred on those persons and their families who have been harmed by the drug. Moreover, depending on the findings of the Inquiry the necessary changes to the ‘system’ need to be put in place to ensure the same failures that occurred here and with Thalidomide do not occur again.
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