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The Medicines and Healthcare products Regulatory Agency (MHRA) has advised 'no one should stop taking valproate without advice from their healthcare professional.' The latest data on the use of valproate in England revealed that in the last 6 months the number of pregnant women prescribed valproate in a 6-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022. In light of concerns that the current regulatory requirements for safe use are not being consistently followed, the MHRA conducted a review of the available data and asked for advice from the independent Commission on Human Medicines (CHM). "The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment," said MHRA. "Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply."

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have authorised community pharmacies throughout the UK to dispense original full packs of Valproate-containing medicines upon prescription. The necessary changes in regulations came into effect on 11 October which was strongly supported by 85 per cent of respondents concerned about risks to the unborn baby if valproate-containing medicines are used in pregnancy. The decision was made to ensure patients receive safety warnings and pictograms, including a patient card and the Patient Information Leaflet (PIL), contained in the manufacturer's original full pack. Valproate is a treatment for epilepsy and bipolar disorder but is also associated with birth defects and neurological disabilities.

The Medicine and Healthcare products Regulatory Agency (MHRA) has cautioned men on valproate to talk to their healthcare professional about their treatment, if they want to start a family in the next year. The warning came after a new study, commissioned by the European Medicines Agency, suggested that children fathered by men who took the anti-seizure medicine in the three months prior to conception may be at higher risk of developing neurodevelopmental disorders. Around five in 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder, compared to three in 100 children whose fathers were taking other antiseizure medicines (lamotrigine or levetiracetam). However, the risk is believed to be much smaller than the risk associated with valproate in pregnancy.