Men taking strong pills for bipolar disorder and epilepsy were warned today about the risk of birth defects in children.
Safety concerns mean Britons must use contraception when taking valproate, to avoid ‘the risk of problems in children’.
Health officials have warned men who take the pill daily that it could increase the risk of “neuro-developmental disorders in children.”
They were also advised not to donate sperm during treatment and for at least three months after stopping treatment.
The ‘precautionary advice’ about valproate side effects follows a safety review by the Medicines and Healthcare products Regulatory Agency (MHRA), which oversees the safety of medicines used in the UK.
Safety concerns mean Britons must use contraception when taking valproate to prevent ‘risk of problems in children’
Health officials have warned men taking the daily pill – which is also used to treat bipolar disorder – that it could increase the risk of ‘neurodevelopmental disorders in children’
The drug calms manic episodes in people with bipolar disorder by blocking nerve signals.
It is also used to prevent epileptic seizures in patients by reducing the amount of electrical activity in the brain that would cause them.
Dr Alison Cave, Chief Safety Officer at the MHRA, said: ‘Valproate is an effective medicine in the treatment of epilepsy and bipolar disorder.
Men taking valproate should be aware that there is now evidence of a possible small increased risk of their child developing a neurodevelopmental disorder if their partner becomes pregnant while they are taking valproate.
Although the risk to a child is lower than the risk if a mother takes valproate during pregnancy, we recommend that men taking valproate and their partners follow the updated guidelines and use effective contraception.
‘Patients taking valproate should not stop taking their medication unless a healthcare provider advises them to do so.
‘It is important that you attend your next appointment to discuss your treatment plan.’
A study by the MHRA found that children of men who took the pill up to three months before conception had a slightly higher risk of developing learning problems than children of men who took other medicines to prevent seizures.
A 2022 report found that since April 2018, 315 women had been prescribed sodium valproate during pregnancy, and 30 women started taking the drug while they were already pregnant. This suggests that expectant mothers are still not being given full information about the risks.
Five out of 100 children born to men who took this medicine were diagnosed, compared with three out of 100 children who took other medicines.
They argue that medical professionals should inform male patients at their next routine treatment about this risk and about other possible treatment options available.
Valproate has been linked to other problems in children of mothers who use the drug.
The drug has been condemned as the ‘new thalidomide’ because of its risk of causing serious malformations and learning disabilities in pregnant women, a reference to the 1960s treatment for morning sickness, which caused life-threatening birth defects.
In 2020, a damning report concluded that the government had failed the 27,000 women taking valproate because many were unaware of the risks. Then-Health Secretary Matt Hancock apologised on behalf of the NHS.
According to the MHRA, the risk to children of fathers who take the drug is ‘much lower than the risk of neurodevelopmental disorders in children of mothers’ who take the drug.
If you have any questions, it is best to contact a healthcare provider.
Any suspected side effects of valproate should be reported via the Yellow Card system.