We have commented regularly on the Sodium Valproate birth defect scandal and, more recently, on the push for a compensation scheme. Now, amid the finding that one in five women taking the drug are still unaware of the risks during pregnancy, the Medicines and Healthcare Products Regulatory Agency (MHRA), which is an agency of the Department of Health and Social Care, has introduced a change to the drug’s licence. This change creates a requirement, among others, that the drug should not be prescribed to girls and women of childbearing age unless they provide informed written consent.
It is also recommended that those who fall into this category who are already taking the medication should contact their GP for a review.
Dr June Raine, Director of MHRA’s Vigilance and Risk Management of Medicines Division said:
“Valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.
“These new regulatory measures also include a ban on the use of valproate for migraine or bipolar disorder during pregnancy, and a ban on the use of valproate to treat epilepsy during pregnancy unless there is no other effective treatment available.
“Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is important women don’t stop taking valproate without first discussing it with their doctor.”
Leading Sodium Valproate Solicitor, David Gazzard, said “I am delighted that the MHRA have stepped in to safeguard the interests of women prescribed Sodium Valproate and to ensure the safety of their unborn children. Regardless of these new measures it has always been my view that health professionals should always ensure that they have the informed consent of their patients before prescribing Sodium Valproate.”