As a result of the link between potent anti-epilepsy drugs and congenital disabilities, strict new prescription regulations have been implemented.
Patients under 55 will no longer be allowed to start sodium valproate treatment without approval from two doctors.
Pregnant women taking the drug may experience severe deformities and cognitive difficulties, earning it the label “new thalidomide.” This reference is to the 1960s morning sickness treatment that led to potentially fatal congenital disabilities.
A damning 2020 report stated the government failed the 27,000 women taking valproate, many unaware of its risks; Health Secretary Matt Hancock then apologized on behalf of the NHS.
The drug prevents epileptic seizures by reducing brain electrical activity, believed to be the cause. It also helps bipolar disorder patients manage manic episodes by inhibiting nerve signals.
Research shows an 11% risk of congenital anomalies, such as cleft palates, tiny fingers and toes, and spina bifida (improper spine development), in infants born to women using valproate. There’s also a 40% chance of developing cognitive issues, including delayed speech or walking.
Valproate: Stricter Rules, Serious Implications
Valproate has been linked to similar issues in the offspring of men using it. A slightly increased risk of cognitive difficulties was noted in children fathered by men who took the drug up to three months before conception, compared to those on other seizure medications, per one study.
Women currently on the drug are also subject to the new prescription rule. They must attend annual reviews, be reminded of the risks, and sign a consent form to continue.
The only other NHS drug requiring two signatures is Roaccutane, an anti-acne medication linked to severe depression and fatalities.
However, consultant neurologist Prof. Ley Sander at London’s National Hospital for Neurology and Neurosurgery warns of unintended consequences of the new measures. “Very few would be prescribed this drug unless necessary,” he says.
Patients needing valproate may need help getting prescriptions approved under the new rules.
For those with generalized epilepsy, this is the only effective treatment. “The stakes are life and death.”