Warnings of risks of epilepsy drug ‘could and should have been given in 1974’

The warnings to young women who might become pregnant that the epilepsy drug sodium valproate could cause birth defects and developmental problems in their babies ‘could have and should have been given in 1974‘, according to campaigners from the Fetal Anti-Convulsant Syndrome Association. Eleanor Sheerin reports

Catherine Cox from the group, which provides help and support to children and their families who have birth defects as a result of the drug, spoke at a public hearing of the European Medicines Agency, which is currently conducting a risk assessment of the drug. Despite the fact that the warnings that are now made public were known to the relevant people over 40 years ago, according to Cox there was ‘a deliberate decision not to publish them‘.

Regulators knew about the risks when they were considering licensing sodium valproate for the control of seizures in epilepsy, with a ‘Dear Doctor‘ letter warning health professionals: ‘This compound has been shown to be teratogenic in animals, meaning it could harm the human foetus.‘

However, documents from 1973 show they thought telling patients ‘could give rise to fruitless anxiety‘, and the Committee on Safety of Medicines said a warning should ‘not [go] on the package inserts, so that there would be no danger of patients themselves seeing it‘.

The revelations follow years of struggle for the families affected by the effects of the drug during pregnancy, which culminated in legal action against the manufacturers of the epilepsy drug Epilim (which contains sodium valproate), involving 100 families seeking compensation on behalf of their children who were born with a range of birth defects including spina bifida, heart damage, cleft palates and deformed hands and feet. The legal battle had to be cut short after the families’ funding was cut off in November 2010. You can read about the background here on the Justice Gap.

Janet Williams, who has five children diagnosed with birth defects and developmental problems as a result of her taking sodium valproate whilst pregnant, said at the time that the Government had ‘failed these children‘ and they ‘don’t want to admit these children have been treated unfairly by the very people supposed to take care of them‘.

The EMA’s risk assessment committee will decide what extra measures should be taken to safeguard young women who might become pregnant and their children from sodium valproate, which is also used to treat bipolar disorder and migraines. Babies whose mothers are given the drug during pregnancy run an 11% risk of birth defects and a 40% risk of developmental problems, and an estimated 20,000 children of the UK have been harmed by their mothers taking the drug.

Whilst many campaigners have been calling for a blanket ban on prescribing the drug for women of childbearing age, doctors argue that for some this is the only drug that can help them control their epileptic seizures. However, according to Janet Williams, ‘parents are oblivious as health professionals don’t give them the correct warnings‘.

Women are still unaware of the risks of the drug, even after a ‘toolkit‘ was produced last year for doctors and patients by the Medicines and Healthcare Products Regulatory Agency, which replaced the Committee on the Safety of Medicines.

Despite these steps taken, they are yet to be proven to be effective. Clare Pelham of the Epilepsy Society said a survey last month of 2,000 young women with the condition found that 68% did not know about it, which is more than the 64% who were unaware last year, when the toolkit had only just been introduced.

Pelham called on the inquiry to make warnings to women mandatory, rather than voluntary, and also for health secretary Jeremy Hunt to require GPs to review any woman on the drug face to face every 12 months. ‘It is a very straightforward measure,‘ she said.

Writing for the Justice Gap in 2012, Janet Williams said: ‘As parents and children we never asked for this in our lives. It was put upon us through the failure of the government, Medicines Board and the drug company, yet it isn’t them left with the devastating and heartbreaking consequences.‘