The UK’s medicines regulator has come up with a new study, issuing a warning to men taking sodium valproate, a medication used to treat epilepsy and bipolar disorder.
They are advised to use contraception while on the medicine due to a potential increased risk of neurodevelopmental disorders in their future children.
The Medicines and Healthcare products Regulatory Agency (MHRA) has also advised men to refrain from donating sperm until three months after stopping the drug. This guidance follows a similar warning from the European Medicines Agency.
Sodium valproate is prescribed under various brand names, including Epilim, Belvo, Convulex, and Depakote. The MHRA stresses that patients must consult their doctors before making any changes to their medication.
Another study from national registries in Norway, Denmark, and Sweden suggested a 5% risk of harm to children born to men taking sodium valproate. Although the study did not prove causality, it raised an important safety issue.
The MHRA has already warned about the potential risks of taking sodium valproate, particularly for babies exposed to the drug in the womb. Neurodevelopmental disorders affect brain function and can range from minor limitations to severe conditions requiring lifelong care.
The Epilepsy Society welcomes the MHRA’s move but believes they could have acted sooner. Chief executive Clare Pelham emphasizes the importance of informed choices for patients with epilepsy.
According to Pelham, sooner.
“It is right for the MHRA to be vigilant as more information becomes available about the risks of epilepsy medication; and to bring this to public attention. They have not always done so. People with epilepsy must be able to make informed choices about the drugs they wish to take.”
The MHRA has estimated that 20,000 children in the UK have suffered life-changing injuries due to sodium valproate. In January, they advised against taking the drug for women and men under 55 unless all other options had been exhausted.
Despite this, 65,000 boys and men under 55 still take sodium valproate. Families affected by the drug have criticized the MHRA for failing to investigate safety issues regarding fathers sooner.
Karen Buck, spokesperson for the support group OACS, took sodium valproate for her epilepsy while pregnant. Her daughter, Bridget, has Fetal Valproate Syndrome and requires 24-hour care. Buck had previously raised concerns about the drug’s effects on men, but was told the MHRA would only examine problems related to women.
The MHRA’s chief safety officer, Dr. Alison Cave, advises patients on valproate not to stop taking their medicine unless advised by a healthcare professional. She emphasizes the importance of attending appointments to discuss treatment plans.
