Mental Health Reform welcomes European Medicines Agency decision on valproate medicines

Mental Health Reform has welcomed the decision by the European Medicines Agency to strengthen warnings on the use of the drug valproate, which is used to treat bipolar disorder, among other conditions, and which has been linked to birth defects and developmental problems in children of pregnant women who have taken the drug.

Dr Shari McDaid, Director of Mental Health Reform, commented: “The Health Products Regulatory Agency must act swiftly to strengthen the warnings given to doctors and patients about the drug valproate. Informed consent, which is a cornerstone of human rights in healthcare, requires that people are given clear information about the benefits, risks and side effects of medication, and that their consent is obtained for treatment. The Department of Health and the Health Products Regulatory Agency must ensure that women of child-bearing age who are prescribed valproate medicines are fully informed of the risks and can make an informed decision about their mental health treatment.”

“Under the Mental Health Commission’s Quality Framework people who use mental health services should be empowered regarding their own care and treatment by exercising choice, rights and informed consent. The risks associated with valproate heighten the need for all health services in Ireland to ensure they fulfil this standard,” concluded Dr McDaid.


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