Strict new prescription rules introduced as anti-epilepsy drug leads to birth defects

Birth defects linked to potent anti-epilepsy pills have led to strict new prescription rules being introduced.

Patients below the age of 55 will no longer be able to start on sodium valproate unless two doctors sign-off on the treatment.

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 drug prevents seizures in epileptic patients by reducing the amount of electrical activity in the brain thought to be to blame. It is also used to calm manic episodes in people who have bipolar disorder by blocking nerve signals.

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

Studies show that babies born to women taking valproate have an 11 per cent risk of defects, which can include cleft palates, small fingers and toes, and spina bifida – where the spine does not develop properly. The chance of learning difficulties, such as late speech or walking development, also stands at 40 per cent.

Valproate has been linked to similar problems in children fathered by men taking the drug, too. 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 new prescribing rule will also apply to women already on the drug. They will have to attend yearly reviews to be reminded of the risks and sign a form agreeing to continue.

The only other drug on the NHS which requires two signatures is the anti-acne drug Roaccutane, which has been linked to serious depression and suicides.

But Prof Ley Sander, a consultant neurologist at London’s National Hospital for Neurology and Neurosurgery, warns the new measures could have unintended consequences. ‘It’s unlikely someone would be prescribed this drug unless there was no alternative,’ he says.

‘These new rules might make life more difficult for patients who can only take valproate for their condition – it could cause delays in getting their prescription signed off.

‘For some people with a type of epilepsy called generalised epilepsy, this is the only effective treatment. This is a matter of life and death.’