Men taking potent pills used to treat bipolar disorder and epilepsy were today warned about the risk of birth defects in children.
Safety concerns mean Brits should use contraception when on valproate, to prevent the ‘risk of problems in children’.
Health officials warned men taking the daily pill that it may increase the likelihood of ‘neurodevelopmental disorders in children’.
They were also urged not to donate sperm during treatment and for at least three months after stopping.
The ‘precautionary advice’ over valproate’s side effects follow a safety review by the Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in the UK.
Safety concerns mean Brits should use contraception when on valproate, to prevent the ‘risk of problems in children’
Health officials warned men taking the daily pill — also used to treat bipolar disorder — that it may increase the likelihood of ‘neurodevelopmental disorders in children’
The drug calms manic episodes in people who have bipolar disorder by blocking nerve signals.
It is also used to prevents seizures in epileptic patients by reducing the amount of electrical activity in the brain thought to be to blame.
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 potential small increased risk of their child having a neurodevelopmental disorder if their partner becomes pregnant while they are on valproate.
‘While the risk to a child is lower than the risk associated with a mother taking valproate in pregnancy, we recommend that men taking valproate and their partners follow the updated guidance and use effective contraception.
‘Patients on valproate should not stop taking their medicine unless advised to do so by a healthcare professional.
‘It is important to attend your next appointment in order to discuss your treatment plan.’
One study found that children fathered by men who took the pill up to three months before conception were at a slightly higher risk of developing learning difficulties than those taking other medicines to prevent seizures, the MHRA said.
A 2022 report found that 315 women have been prescribed sodium valproate during pregnancy since April 2018 and 30 started taking the drug when already pregnant, suggesting that expectant mothers are still not receiving full details of the risks
Five in 100 children fathered by men on the drug received a diagnosis, compared to three in 100 on other medications.
Health professionals should inform male patients about this risk at their next routine treatment review and other potential treatment options available, they added.
Valproate has been linked to other problems in children born to mothers taking the drug.
The medication has been condemned as the ‘new thalidomide’ due to its risk of causing serious deformities and learning difficulties when taken by pregnant women — a reference to the 1960s morning sickness treatment which caused life-threatening birth defects.
A damning report in 2020 concluded the Government had failed the 27,000 women taking valproate as many were unaware of its risks, with then Health Secretary Matt Hancock apologising on behalf of the NHS.
The risk to children born to fathers taking the drug is ‘much lower than the risk of neurodevelopmental disorders in children born to mothers’ on it, the MHRA said.
Anyone with questions should also speak to a healthcare professional.
Any suspected side effects associated with valproate should be reported via the Yellow Card scheme.
