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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.

Healthcare professionals in the UK are being advised to avoid prescribing the migraine and antiseizure medication topiramate, commonly known by the brand name Topamax, to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme. This guidance follows new safety measures introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) following a major safety review, which highlighted a potential increased risk of neurodevelopmental disabilities in children exposed to topiramate during pregnancy. The Commission on Human Medicines (CHM) evaluated studies that examined the risks associated with using topiramate during pregnancy. These studies indicated that children born to mothers who took topiramate during pregnancy had an approximately 2 to 3 times higher risk of intellectual disability, autism spectrum disorders, and attention deficit hyperactivity disorder. Based on CHM's recommendations, the MHRA now advises that topiramate should not be prescribed for treating epilepsy during pregnancy unless there is no suitable alternative.