Strict new prescription rules introduced because anti-epilepsy drugs lead to birth defects

Birth defects linked to powerful anti-epilepsy pills have led to the introduction of strict new prescription rules.

Patients under 55 years of age can no longer start sodium valproate unless two doctors sign off on the treatment.

The drug has been condemned as the ‘new thalidomide’ due to its risk of causing serious deformities and learning problems when taken by pregnant women – a reference to the morning sickness treatment of the 1960s, which caused life-threatening birth defects.

A damning 2020 report concluded that the government had failed the 27,000 women taking valproate because many were unaware of its risks, with then Health Secretary Matt Hancock apologizing on behalf of the NHS.

The drug prevents seizures in epilepsy patients by reducing the amount of electrical activity in the brain that is thought to be the cause. It is also used to calm manic episodes in people with bipolar disorder by blocking nerve signals.

A damning 2020 report concluded that the government had failed the 27,000 women taking valproate because many were unaware of its risks, with then Health Secretary Matt Hancock apologizing on behalf of the NHS.

Research shows that babies born to women taking valproate have an 11 percent risk of developing abnormalities, including cleft palate, small fingers and toes, and spina bifida – where the spine does not develop properly. The chance of learning problems, such as late speech or walking development, is also 40 percent.

Valproate has also been linked to similar problems in children fathered by men using the drug. One study found that children fathered by men who took birth control pills for up to three months before conception were at slightly greater risk of developing learning problems than children who took other medications to prevent seizures.

The new prescribing rule will also apply to women who are already using the drug. They will have to attend annual reviews to be reminded of the risks and sign a form agreeing to proceed.

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

But Prof Ley Sander, consultant neurologist at London’s National Hospital for Neurology and Neurosurgery, warns the new measures could have unintended consequences. “It is unlikely that anyone would receive this drug unless there was no alternative,” he says.

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

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