Sodium Valproate: Everything you need to know about the risks of the drug and its history
Watch an ITV Meridian vodcast where Social Affairs Correspondent Christine Alsford speaks at length to Carole McNeil and Jo Gamblin.
What is Sodium Valproate?
It's a drug used to treat epilepsy. In the past it was used for bipolar disorder and migraine.
What problems can it cause?
Birth defects including spina bifida, cleft palette, malformations of the limbs and sexual organs, heart, kidneys, and urinary tract. Developmental delays including delayed walking and talking, poor speech and language, lower intelligence and memory problems. And there is an increased risk of autism or autism spectrum disorders and possibly ADHD.
How long has the drug been given to women in England?
It was first used in 1973 - but only given a licence for year for specialist centres and hospitals. In 1974 a full licence was granted on the basis that doctors were warned specifically about how it can cause birth defects or developmental abnormalities in animals.
Why have women ended up taking the drug during pregnancy?
Often women have been taking the drug long term to control their epilepsy and have then become pregnant without discussions about whether that medication should be reviewed or changed by their doctors before conception. In several cases women have been in contact with fertility services or GPs about their pregnancies and information and knowledge has been lacking or not passed on about the potential risks. But in other historic cases they say they have asked experts including neurologists about the safety of the drug in pregnancy and been reassured only to find their children have then been affected. For some sodium valproate is the only drug that will control their seizures.
What increased risk of birth defects and other problems does it have?
Around 1 in 10 babies whose mothers take valproate while pregnant will have a birth defect. Two or three babies in every 10 may have developmental delays.There is evidence children are more likely to have autism or autism spectrum disorders and possibly ADHD.
Why are women speaking out about this now?
In many cases they are getting older and are worried about how their children will be looked after in the future. Several have been fighting for many years for redress. There is frustration that legal cases have collapsed, reviews by the government have not resulted in action and a major report that was published well over a year ago by the Patient Safety Commissioner has not had a response from the government. The government say they are working to provide an update "at the earliest opportunity".
Why hasn't sodium valproate been banned?
It is a very effective drug for epilepsy which can be a life threatening condition - and for some will be the only drug that will control seizures. Since 2018 it has been banned to treat epilepsy during pregnancy unless there is no other effective treatment available. No patient should stop taking valproate without advice from a specialist.
Why did it take so long for warnings about the medication to be passed on?
From 1974 health professionals were warned about potential dangers but this information wasn't always passed on to women and their families. At this stage it was known that the drug caused birth defects in animals like mice at high doses. A letter to doctors from the Committee for the Safety of Mediciens in 1974 decided not to inform patients directly because it would cause "fruitless anxiety".
As more studies were carried out and evidence emerged, the first patient information leaflet was introduced in 1989. This said that pregnant women and those who may become pregnant should consult their doctor - but there was no indication why. These warnings were later strengthened and became more detailed - particularly on the risk of spina bifida.
It took nearly 30 years after this for warnings about the drug being taken in pregnancy to be added to boxes and pill packets (2018). The medical regulator, the MHRA, says while legislation now requires that patients be directly provided with information about their medicine, in the 70s and 80s few medicines were supplied with any printed information for patients.
What safeguards are in place about taking sodium valproate now?
Strips of pills have prominent pictorial warnings saying the drug shouldn't be taken in pregnancy - so do the boxes.
Patient information leaflets included with the medication explain the harm it can cause - and how it must not be used in pregnancy.
Women who are under 55 and taking valproate should be included in the Pregnancy Prevention Programme. This programme tightly controls who should take valproate and has to be signed off by two specialists.
There is also increased awareness of the need to warn men too who are on sodium valproate as birth defects can be passed on via fathers who take the drug as well.
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