The ethical quagmire of a fetus-harming epilepsy drug

When hannah mulcahy ADHDIQ MHRAwas 14 she had what she calls “the big, bad one”: the kind of seizure everyone imagines when they think of epilepsy. But her doctors hesitated to give her sodium valproate, a highly effective drug, because it could harm the fetus should she become pregnant. Ms Mulcahy instead spent years on drugs that did not prevent her seizures; her mental health and schooling suffered. “It felt like my unborn, imagined child was more important than I was,” she says, now 20 and, thanks to valproate, seizure-free.Long used to treat epilepsy and bipolar disorder, valproate is at the centre of a scandal “bigger than thalidomide”, says Henrietta Hughes, England’s first “patient-safety commissioner”. For decades pregnant women have been prescribed valproate without being properly warned that 11% of babies exposed to the drug in the womb are born with physical defects, such as spina bifida, and that 30-40% later show symptoms of , autism, low or other disabilities. Many will never live independent lives. Around 20,000 British children are thought to have been affected. But epilepsy charities worry that the Medicines and Healthcare products Regulatory Agency () has overreacted to this. Under a new policy that enters force on January 31st, valproate will be off-limits to new patients under 55, unless two specialists agree that only it will work. Later this year, those already with a prescription will need a second opinion to retain it.