The Medicines and Healthcare products Regulatory Agency (MHRA) has recently revised its guidance on the use of sodium valproate in men under the age of 55. Previously, men in this category required a review by two specialists before continuing treatment. However, the dual review requirement has been removed for those already on the medication. This change comes amid concerns about valproate's teratogenic potential and associated developmental risks.
Valproate is known for its effectiveness in treating certain types of epilepsy, including idiopathic generalized epilepsies. Despite its benefits, the drug carries significant risks, including a 10% likelihood of birth defects and a 40% risk of developmental problems. Recent research also suggests a possible increased risk for neurodevelopmental disorders in children born to men treated with valproate within three months prior to conception.
The MHRA advises that men currently on valproate should discuss their family planning intentions during their next medical review. They should also be counseled on using effective contraception alongside their female partners while taking the drug, and for three months after discontinuation.
In conjunction with the MHRA's update, the National Institute for Health and Care Excellence (NICE) has revised its guidance to reflect the new stance. Valproate remains a recommended treatment option for specific syndromes such as Dravet and Lennox-Gastaut, where it is considered the most effective treatment. However, alternative medications like lamotrigine and levetiracetam are now recommended as first-line monotherapy options for many epilepsies.
The Association of British Neurologists (ABN) issued a statement acknowledging the challenges posed by the ruling for patients and healthcare providers. They emphasized the importance for clinicians to:
"recognise and adopt the new regulatory framework, balancing the risk from seizures with the reproductive risk from medication" – The Association of British Neurologists (ABN)
Furthermore, the ABN reassured that:
"Valproate can, with appropriate counselling and documentation, still be used" – The Association of British Neurologists (ABN)
While the dual review process is no longer required for men under 55 currently on valproate, it remains in place for new male patients under 55 and women unless reproductive risks are not applicable.
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