More than 100 pregnant women have been exposed to medication for epilepsy and bipolar disorder which carries a high risk of birth defects, as the government’s independent medical and scientific committee opted against recommending stricter prescribing rules for the drug.
Freedom of information (FoI) documents show the Advisory Committee on Medicines (ACM) met in April to consider changing the prescribing requirements for the drug, sodium valproate, after the UK introduced tougher regulations in January.
Of babies exposed to valproate during pregnancy, about 10% were born with birth defects and up to 40% were at risk of permanent developmental disorders, UK and Australian therapeutic guidelines state.
Sophie Gardner, who runs an online support group for Australian families affected by foetal valproate syndrome, says many were not aware of the risks from the medication until after their children were born.
The mother of two feels “Australia’s just so far behind” countries such as the UK.
“There are court cases happening around the world, compensation schemes have been proposed … Australia just seems to have its head in the sand when it comes to this drug.”
Gardner, who lives in Victoria, took valproate to treat her epilepsy during both her pregnancies and says she was not sufficiently informed about the possibility her medication could cause birth defects.
“The concern was more about my actual epilepsy,” a brain disorder that causes recurring, unprovoked seizures. As long as she didn’t have a seizure, she says she was told, her baby would be OK.
The five-month ultrasound for her first child found a bone deformity, with his foot “growing at a 90 degree angle”.
“At the time, I was just delighted to have this beautiful baby boy and didn’t take much notice,” Gardner says.
Her second son was diagnosed with a chronic blood disorder. “We kept thinking the kids are having such bad luck with their health,” she says.
But when she discovered mothers in the UK raising awareness of foetal valproate syndrome, it cemented her fears the drug may have affected her children.
A doctor advised her that sodium valproate might be one factor affecting both boys’ development. Gardner says a board of paediatricians, including neurologists, who then assessed clinical information about her sons confirmed both had been exposed to and affected by the drug.
To reduce risks for pregnant women, the UK now requires review and signoff from two medical specialists before prescribing valproate to anyone aged under 55, along with other safety measures.
Australia’s drugs regulator, the Therapeutic Goods Administration (TGA), asked the ACM for advice on whether similar changes should be made, FoI documents showed, noting the high quality of the UK’s evidence and guidance.
The documents noted that the TGA had reported 109 cases of pregnant Australian women exposed to sodium valproate since 2004. Sixty of those cases occurred since 2018, when the TGA requested more stringent pregnancy warning pictures and alerts for health professionals on sodium valproate products. It caveated that there was the possibility of duplicates in some of the total case numbers.
After considering the evidence, the ACM determined that current Australian prescribing measures, which include counselling for women of childbearing age and warning labels, were sufficient. The ACM cited several reasons for its stance, including concerns about the “substantial burden” on doctors if they were required to get a second specialist to sign off.
The ACM noted uncertainty about how additional restrictions would affect prescribing practices in Australia, and that gender-based prescribing restrictions had been previously ruled out because of concerns about administrative complexity and equality of access, the documents showed.
But one pharmacy expert and advocates for prescribing changes questioned the ACM’s recommendation, concerned that existing measures do little to address gaps in the safeguarding of women and their pregnancy.
Prof Barbara Mintzes, a specialist in pharmaceutical policy at the University of Sydney, does not believe gender equity concerns about access to medication should trump “an overriding desire not to have exposures in pregnancy for a drug that’s risky for use”.
“Sometimes you need to take stronger action, because you already have evidence that what has been done before has not completely prevented exposure,” she says. One measure she wants considered in Australia is “written informed consent” from patients, similar to the risk acknowledgment form required in the UK.
Prof Terence O’Brien, a co-investigator at the Australian Pregnancy Register, is collecting information on women with epilepsy who become pregnant to help identify which anti-epileptic medications are safest for the baby while also protecting the mother from seizures. Epileptic seizures during pregnancy can cause miscarriage or serious harm to both mother and baby.
O’Brien acknowledges the “really quite considerable” risks of sodium valproate to unborn children, saying there is “a whole variety of different types of birth defects … across virtually every system”. He also highlights more recent findings of the drug’s potential “effects on brain development, causing neurocognitive problems, even behavioural changes such as autism spectrum disorder”.
But he still believes the ACM recommendation is the right one.
“For some people, sodium valproate is the only drug that can adequately control their seizures,” he says.
“We now have at least 16 anti-seizure medications on the market but valproate has a unique spectrum of action … particularly in a group of epilepsies called genetic epilepsy … where it is unquestionably the most effective drug in terms of seizure control.”
O’Brien, who has declared research support from the pharmaceutical company Sanofi, which produces sodium valproate, says harms had arisen from the tighter UK prescribing regulations, pointing to injuries and deaths among women who stopped taking valproate and suffered seizures. Sanofi’s valproate guidelines emphasise that people should not stop taking the medication without consulting their doctor; NHS guidelines stress the same advice.
Carol Ireland, the CEO of Epilepsy Action Australia, is also concerned that if similar restrictions to those imposed in the UK are introduced in Australia, many people with epilepsy would find it harder to access highly effective medication.
“Clinical practices have evolved, with a marked reduction in the average daily dose of valproate prescribed to pregnant women, contributing to a decline in the rate of foetal malformations,” Ireland says.
But Mintzes is concerned the data in the FoI documents doesn’t show the extent of the exposure during pregnancy in Australia.
“There is an overall general problem globally of adverse event reports from exposures to drugs being subject to under reporting,” she says.
A spokesperson for the TGA says it has robust processes for ongoing monitoring of the safety of all medicines on the Australian Register of Therapeutic Goods (ARTG).
They noted that “every brand of sodium valproate in Australia now contains a pictogram and written warning regarding the known risks of use in pregnancy on the outer packaging”, but also acknowledged “the importance of the informed consent process” during prescribing.
“In recent years, the issue of the use of sodium valproate in pregnancy and people of child-bearing potential has been reviewed by the TGA in 2014, 2018 and 2024,” the spokesperson says.
“The advice provided by the ACM has been used to guide the TGA’s investigation, which is ongoing.”
Do you know more? Contact natasha.may@theguardian.com
