Cegedim Healthcare Solutions has been notified that new safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males. These safety and educational materials support the new regulatory measures announced in the National Patient Safety Alert.
Full details published by the Medicines and Healthcare products Regulatory Agency (MHRA) are available on the GOV.UK website: https://www.gov.uk/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-new-safety-and-educational-materials-to-support-regulatory-measures-in-men-and-women-under-55-years-of-age
