Fetal Anti-Convulsant Syndrome and its association with the Drug Epilim
Studies have emerged which show that babies born to mothers who take valproate-containing medicines (licensed as Epilim) during pregnancy have a 30%-40% risk of developmental disability and a 10% risk of birth defects (broadly known as Fetal Anti-Convulsant Syndrome). Fetal Anti-Convulsant Syndrome is a group of malformations that can affect some babies if they are exposed to anti-epileptic medications, while in the womb.
Who is at Risk?
1,700 women have been identified to have been at risk. These women are of child bearing age and are being prescribed this drug to treat conditions such as Epilepsy, Bipolar Disorder and Migraines. This drug has been licensed in Ireland since 1983, and it is estimated by FACS forum that up to 400 babies may have been born in Ireland with FACS.
European Medicines Agency Recommendations
In the early 2000’s, a link between babies diagnosed with developmental delay, Autism and ADHD and the anti-convulsant drug Epilim, were established. Recommendations made by the European Medicines Agency (EMA) in 2014 and again in February of this year, have cemented the seriousness of this. As a result of these findings, countries such as France and UK have taken action and implemented the recommendations. Sadly, Ireland has been slow off the mark with its implementing of these recommendations.
The latest recommendation made by the EMA include:
- Where the purpose of the prescription is to treat migraine or bipolar disorder, Valproate should not be prescribed during pregnancy;
- When a female is of child bearing age, Valproate should not be prescribed unless a pregnancy prevention programme is in place;
- For females who have been diagnosed with Epilepsy, Valproate should not be prescribed during pregnancy, unless is it absolutely necessary wherein specialist care should be arranged for the patient;
- Outer packaging of Valproate must include a visual warning in relation to the risks associated with taking this drug while pregnant;
- A patient reminder card should be attached to the box on dispensing of the medication to remind Pharmacists to discuss the risks with the patient each time it is dispensed;
- Pharmaceutical companies that market Valproate should issue informative pamphlets to healthcare professionals and patients;
These recommendations are currently being considered by the European Commission and a legally binding decision is expected.
Open Disclosure/Actions Taken
Keeping in mind the Health Service Executive’s open disclosure policy, one would expect, the information to have been directly communicated with those at risk. Unfortunately, this is not the case, and direct communication from the HSE with these women (whose names and addresses are known to the HSE) has yet to occur. The first action taken by the HSE (in conjunction with the Health Products Regulatory Authority) was in February 2018, wherein a letter was sent to GPs requesting they identify their (female) patients who have been prescribed the drug and let them know of the potential risks in taking this drug during pregnancy. The next step was March 2018, wherein the HSE wrote a similar letter to pharmacists. It is shocking to think that the risks associated with this drug has been known to the HSE for many years (through communications with the European Medicines Agency and other Agencies like this), however up until recently very little action has been taken by the HSE in offering any guidance to healthcare professionals (not to mind patients) on how this can be managed. It appears to be the position that the Health Service Executive know (or at least have the ability to find out) the identity of females, who during their pregnancy took this drug and subsequently gave birth to a child with disabilities. These females are totally unaware of the possible connection and are being kept in the dark by the HSE, notwithstanding its open disclosure policy. The HSE should now immediately contact those females and advise them that there may be a connection between the drug and their babies disabilities.
Compensation Scheme for those Affected
Minister Harris met with representatives from the Fetal Anti-Convulsant Syndrome Group in April 2018 to discuss the possibility of compensating women and children affected by this. The group were advised that the Minister is considering this and they would be contacted by the end of the month with his view on this.
Of note, the UK and France have conducted reviews on this and a compensation scheme has been put in place in France for those affected. One would hope that the Minister will follow suit. It is crucial that a comprehensive plan (with regards to both diagnosis, treatment and compensation) is put in place to tackle this potentially devastating situation.
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