On March 21, 2018, CMDh1 approved new measures to prevent babies from being exposed to valproate-based drugs in the womb, with babies exposed at high risk of malformations and developmental problems. Additional copies of the patient information brochure containing valproate are available for download. In women who take valproate during pregnancy, about 1 in 10 babies will have a birth defect. The regulatory measures, announced after a comprehensive risk review in 2018, also include a ban on the use of valproate for migraine or bipolar disorder during pregnancy and a ban on the use of valproate to treat epilepsy during pregnancy, unless there is other effective treatment. In women who take valproate during pregnancy, about 3 to 4 out of 10 children may have developmental problems. The long-term effects are not known. As part of the pregnancy prevention programme, health professionals are responsible for the safe prescribing of valproate managers: companies that market these drugs are also required to carry out further studies on the nature and extent of risks and to monitor the consumption of valproate and the long-term effects of the pregnancies concerned. Sodium valproate, valproate-magnesium, half-sodium valproate, valproic acid, valpromide If you are taking valproate and you think you are pregnant or know you are pregnant, contact your doctor immediately so that you can discuss your options. Taking valproate during pregnancy presents a significant risk of birth defects and developmental disorders. British Paediatric Neurology Association (BPNA) and the Royal College of Paediatrics and Child Health (RCPCH) – A joint guide to the use of valproate in women under the age of 18.
The following resources are available to help health professionals understand their clinical responsibility for valproate: Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women taking valproate during pregnancy. Information on the risks of taking valproate during pregnancy. Children exposed to valproate in the womb are more likely to have autism or autism spectrum disorders. There is also some evidence children may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD). Through cooperation across the health sector, these measures will help to minimize the number of ways of thinking about valproate-based medicines and to ensure that all women and girls with child-negativeness are fully aware of the risks involved. Royal College of General Practitioners and Association of British Neurologists and Royal College of Physicians – Clinical guidance to support healthcare professionals involved in the care of women on valproate. If valproate is taken during pregnancy, up to 4 out of 10 babies are at risk of developmental disorders and about 1 in 10 are at risk of birth defects. Companies that market valproate should conduct further studies to characterize the nature and extent of the risks associated with the use of valproate and to monitor the continued use of valproate and the long-term effects of the pregnancies involved.