Men on sodium valproate told to use contraception
Men taking sodium valproate are being warned to use contraception while on the medicine, because of a "potential small increased risk" of autism and other neurodevelopmental problems for any children conceived.
They should continue to do so - and cannot donate sperm - until three months after they have stopped taking the drug.
Sodium valproate, prescribed under brand names including Epilim, Belvo, Convulex and Depakote, is an effective treatment for epilepsy and bipolar disorder.
The Medicines and Healthcare products Regulatory Agency (MHRA), which issued the warning, stressed patients must speak to their doctors before making any changes to their medicines.
The guidance follows a similar warning from the European Medicines Agency, after data from national registries in Norway, Denmark and Sweden suggested 5% of children born to men taking the drug were harmed.
That study did not prove sodium valproate was the cause, the MHRA said, or compare risks for children whose fathers were not on medication.
But it raised an "important safety issue that warrants action on a precautionary basis".
Source: BBC News, 5 September 2024