Men who are currently taking sodium valproate are being strongly advised to use contraception to mitigate the potential risks associated with the medication. This precaution is recommended due to a “slightly increased risk” of autism and other neurodevelopmental disorders in children conceived during treatment. The guidance also stipulates that men should continue using contraception and avoid sperm donation for three months after discontinuing the medication.
Sodium valproate, available under brand names such as Epilim, Belvo, Convulex, and Depakote, is commonly prescribed for epilepsy and bipolar disorder. The warning, issued by the Medicines and Healthcare products Regulatory Agency (MHRA), underscores the importance of consulting healthcare providers before making any changes to medication.
The new advisory comes in response to concerns raised by the European Medicines Agency, which reviewed data from Norway, Denmark, and Sweden. This data suggested that up to 5% of children born to men taking sodium valproate may experience adverse effects. While this research did not establish a direct causal link or compare the risks with those of fathers not on the medication, it highlighted a significant safety concern warranting precautionary measures.
The MHRA had already recognized sodium valproate’s potential impact on fertility, noting that difficulties in conceiving are typically reversible after discontinuation of the drug. However, the latest guidance is an additional step to address emerging evidence about the medication’s effects on offspring.
Clare Pelham, Chief Executive of the Epilepsy Society, commended the MHRA’s decision but expressed disappointment that such measures were not implemented sooner. “It is crucial for the MHRA to remain vigilant as new information about epilepsy medications becomes available and to ensure public awareness. People with epilepsy need to be fully informed about the risks associated with their treatments.”
The medication’s known risks include a 40% chance of autism and other neurodevelopmental disorders, and a 10% risk of physical abnormalities for babies exposed to sodium valproate in utero. Approximately 20,000 children in the UK have been significantly affected by the drug.
Families and advocacy groups, such as OACS, have long criticized the MHRA for not addressing the safety concerns related to male patients earlier. Karen Buck, a spokesperson for OACS, highlighted her personal struggle with the drug and criticized the MHRA for delaying action on the issue.
In January, the MHRA advised that individuals under 55 should only use sodium valproate if all other treatment options have been exhausted and with approval from two independent specialists. Despite these recommendations, around 65,000 children and adults under 55 continue to use the medication.
Dr. Alison Cave, MHRA Chief Safety Officer, emphasized, “Patients should not stop taking sodium valproate without consulting a healthcare professional. It is essential to discuss your treatment plan at your next appointment.”
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