UK Edition
An epilepsy drug which can cause birth defects is being given to too many women, the patient safety tsar warned, as she claimed it was a “bigger scandal than Thalidomide”.
Sodium valproate, which is used to treat epilepsy and bipolar disorder, can cause problems for a baby’s development if given during pregnancy, including birth defects.
The Medicines and Healthcare products Regulatory Agency (MHRA) ruled in 2018 the drug should no longer be prescribed to women of “childbearing potential” due to the risk.
In December it announced further safety measures, including needing two independent specialists to sign off on the drug for any patients aged 55 years or younger.
NHS England also set a target to reduce the number of women taking the drug by half by the end of 2023.
But analysis of data by The Pharmaceutical Journal has revealed the number has only been reduced by 28 per cent between April 2018 and March 2022, from 27,411 to 19,766.
Patients 'not always informed' of potential harm
Henrietta Hughes, the patient safety commissioner for England, told the journal she was “very disappointed” so many women were still taking the drug while at risk of pregnancy.
She said: “The target to halve the number set by NHS England is unlikely to be met and patients are not always informed of the harm that can occur. Three babies a month are still being born after exposure to sodium valproate. This is a far bigger scandal than thalidomide.
“The government urgently needs to listen to patients, commit to financial redress for families who have suffered and not kick this issue into the long grass.”
A spokesperson for NHS England said: “The NHS has established an expert group to help reduce the prescription of valproate to women and girls who could get pregnant, and new rules coming into force next year will mean no patient under the age of 55 will be prescribed it unless two specialists agree it is the only medication available, which will make a further significant contribution to reducing use.
“The NHS has also written to all women and girls aged between 12–55 in England on the medication to remind them of risks of taking it while pregnant, and is working with its partners on initiatives to further reduce valproate risks.”