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A new report by the Health and Social Care Committee says it is “unacceptable” that children are still being born to mothers who were not informed of the risks of sodium valproate.
The report, Follow-up on the IMMDS report and the Government’s response, evaluates how England’s healthcare system responds to reports about harmful side effects from medicines and medical devices.
The Committee specifically considered sodium valproate (as well as vaginal mesh) and found that the health system failed to provide proper support, guidance and care to women even when it was known that harm was occurring.
Various recommendations were made in the Independent Medicines and Medical Devices Safety (IMMDS) report published more than two years ago, but the Committee found the government has been slow to act on its commitments.
Sodium valproate still prescribed to pregnant women
According to Government guidance, sodium valproate (used to treat epilepsy and bipolar) must not be prescribed to any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place.
This is because the drug can cause problems for a baby’s development, including birth defects and long-term learning disabilities (collectively known as Foetal Valproate Spectrum Disorder or FVSD).
However, since April 2018, 286 women have been prescribed sodium valproate in a month in which they were pregnant. The women the committee spoke to said that PPP “really has not got going” and that doctors are still failing to inform patients about the risks of the drug.
According to a report published in August 2022, nearly one in five (17.6%) patients said they had not discussed the need for appropriate contraception while on sodium valproate with their GP or a specialist within the last 12 months.
While the number of pregnant women on sodium valproate is decreasing year on year, the Committee says it is “unacceptable” that mothers are still not being properly advised and supported to change their medication to one less likely to harm their unborn child.
This is particularly pertinent now as new research suggests that people affected by sodium valproate exposure as an unborn baby could potentially pass on effects to their children, according to Dame June Raine.
The Committee says it is “concerned” that data on reports of transgenerational effects has not been collected in the UK. “We cannot understand how it is not in the interest of the Government to monitor transgenerational effects in those affected here in the UK, and would welcome an explanation from the Minister on this,” the Committee writes.
Patients who have been avoidably harmed should be able to claim financial redress
The Committee conclude that very little has been done to engage with women who have lived experienced of these harms and argues that more needs to be done to provide support for the women and children affected.
The Committee also suggests that those affected by the harmful affects of sodium valproate should receive “financial redress”. They propose the establishment of a Redress Agency to provide compensation to those who have experienced avoidable harm. This should be based on whether that harm occurred due to systemic failings, instead of placing blame on individuals.
The Committee says the Agency should operate on the ombudsman model, listening to both sides, investigating impartially, and reaching a decision. “The onus is not on the injured party to prove their case,” they write.
The Committee is also urging the government to put a “rigorous” system in place to ensure standards don’t slip and to protect more mothers and children from avoidable harm. This includes recording when patients have been prescribed sodium valproate to ensure the health system does not continue to ‘fly blind’.