Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the Deputy for raising this important question. I had an excellent meeting with FACS Forum Ireland two or three weeks ago in Leinster House. A number of Deputies had requested the meeting. I met FACS Forum Ireland with representatives of my Department and the HSE.

Sodium valproate is a medicine licensed for use in Ireland to treat epilepsy and bipolar disorder, and is marketed in Ireland under the brand name Epilim. It is now well established that children exposed to valproate in the womb have an increased risk of congenital malformations and developmental disorders, often described as foetal anticonvulsant syndrome, FACS. In 2014, the European Medicines Agency, EMA, conducted a review of valproate and issued advice placing additional restrictions on the use of valproate for women and girls.

In March 2017, the EMA's risk assessment committee initiated a new review of the use of valproate in the treatment of women and girls who are pregnant or of childbearing age. This review has now been concluded and the committee’s new recommendations on sodium valproate were published by the EMA in February.

Some of the key measures recommended by the EMA are that valproate must not be used in pregnancy for the treatment of migraine or bipolar disorder; valproate must not be used in pregnancy for the treatment of epilepsy unless there is no other treatment option available - some women may have to continue treatment with appropriate specialist care in pregnancy; valproate must not be used in female patients from the time they become able to have children, unless the conditions of a new pregnancy prevention programme are met; the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy; and a patient reminder card will also be attached to the outer package for pharmacists to discuss with the patient each time the medicine is dispensed.

The HSE is working with my Department and other stakeholders, such as the Health Products Regulatory Authority, HPRA, and the Pharmaceutical Society of Ireland, to communicate and implement the recommendations of the EMA review. Yesterday, the HPRA issued a drug safety newsletter on sodium valproate to all relevant healthcare professionals, together with updated safety information from the drug's manufacturer. Both of these communications reflect the new EMA recommendations and restrictions.

Additional information not given on the floor of the House

I recently met with members of the FACS Forum Ireland to discuss the new EMA recommendations and other issues relating to the use of sodium valproate and children affected by foetal anticonvulsant syndrome. I have asked Department officials and the HSE to follow up on the issues raised at that meeting and I know that there will be further engagement with FACS Forum Ireland over the coming months.

At present, health-related therapy supports and interventions for children can be accessed through both the HSE's primary care services and its disability services, depending on the level of need. It is estimated that 95% of people’s health and social services needs can be met in a primary care setting. The specialist disability services look after children with more complex needs.

It is important to note that patients currently taking medicines containing valproate are advised not to stop taking these medicines and, if they have any concerns about their specific drug treatment and management of their condition, to discuss these with a healthcare professional.

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