An international cohort study assessing the morbidity and mortality risks of valproate withdrawal in men and women aged 16–54 years with epilepsy

People with epilepsy experience seizures, which are treated with antiseizure medications. Valproate is one of the most effective antiseizure medications available. However, when taken during pregnancy, valproate harms 10–48% of babies. Therefore, the guidance is that valproate should not be used in young women.

New evidence suggests valproate lowers fertility in men and also harms babies born from men taking it. Therefore, guidance will be released imminently to also limit valproate use in men.

As valproate is such an effective antiseizure medication, it is possible some men or women having their valproate stopped will come to harm.

To investigate this, I will undertake an international study assessing thousands of men and women aged 16–54-years who are taken off valproate. I’ll compare them to those remaining on valproate. I will do this using electronic health research data that are fully anonymised and come mainly from the US and UK.

I’ll compare the groups for death, hospital admission, seizures, falls, injuries, burns, chest infections, depression, and self-harm/suicide.

Therefore, I will be able to see if those taken off valproate will experience more of these problems compared to those remaining on valproate.

The study will benefit people with epilepsy as many who are perfectly stable and happy on their valproate will be asked to consider coming off it because of its side effects and the new guidance coming out. They will want to know what the risks of doing that are. This study will provide evidence to help doctors answer that question.