Dr. Colm Henry:

There has always been an awareness of this teratogenic effect in utero. In recent years there has been a growing awareness, not just of the impact of the drug, but also around the frequency with which children can be affected. As the information became more available to us though Europe and through other healthcare systems our priority was to address the immediate safety need in ensuring that all women of child bearing age were made aware of the risk of the drug. Equally, we wanted to be sure that nobody stopped the drug abruptly because that could lead to harm for people who had well controlled epilepsy, for example. As part of the work we have been doing in the summer, and I pay tribute not just to my own team but also to the patient representatives on the FACS forum who have contributed hugely to this work, we have communicated with 2,500 women of child bearing age who have been on the drug.