15-05-2015 | New Valproate educational materials distributed

15 May 2015
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Following the European Medicines Agency decision relating to strengthening the warnings on the use of valproate in women and girls, Sanofi (the manufacturer of Epilim) have this week distributed new educational materials about the risks associated with the drug in female children, women of childbearing potential and pregnant women.

The materials have been approved by the Health Products Regulatory Authority and have been sent to health professionals including neurologists, psychologists, GPs, family planning centres and others.

In addition to a guide for prescribers, the materials also consist of a patient information booklet (which the doctor can give to the patient) as well as a patient information form/ checklist which can be used to guide discussions between the doctor and patient and which can be stored on the patient file.

You can download the patient information booklet from the Sanofi Ireland website.

Epilepsy Ireland welcomes this move, which was mandated by the European Medicines Agency in November last. We hope that increased dialogue and more informed decisions can now be made around the risks involved.

A recent online survey conducted by Epilepsy Ireland of 131 women/ parents of girls taking Valproate found that awareness of the issue was quite poor and that discussions were not yet commonplace between health professionals and patients.

For example, of the 52 respondents who had appointments with their medical professional since the European ruling, only 8 said that the new restrictions had been discussed. Only 3 of the 131 people surveyed had been proactively contacted by their medical team (phone call, letter etc) in the same period.

Epilepsy Ireland and the other members of the FACS Forum - Disability Federation Ireland, Genetic and Rare Diseases Organisation, Medical Research Charities Group and the Organisation for Anti-Convulsant Syndromes Ireland – will continue to monitor the situation.

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