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Home / New Zealand

Anti-epileptic drug sodium valproate faces restrictions after 26 babies born with serious disorder

Amy Wiggins
By Amy Wiggins
Education reporter, NZ Herald.·NZ Herald·
5 Mar, 2019 04:00 PM4 mins to read

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Foetal Anti-Convulsant Syndrome NZ executive officer Denise Astill, right, with twin daughters Jazmyn, left, and Natasha who were born with the disorder. Photo / Supplied

Foetal Anti-Convulsant Syndrome NZ executive officer Denise Astill, right, with twin daughters Jazmyn, left, and Natasha who were born with the disorder. Photo / Supplied

At least 26 babies have been born with foetal anti-convulsant syndrome in New Zealand as a result of their mothers taking a prescription drug used to treat epilepsy and bipolar disorder.

This week, Medsafe imposed greater restrictions on the prescription of sodium valproate, also known as Epilim, so that it could only be used to treat women with bipolar disorder as a last resort and not at all during pregnancy. A specialist will also be required to first prescribe the drug to a woman.

The drug was also not to be used during pregnancy for epilepsy unless there was no suitable alternative.

But advocates say the changes do not go far enough.

Healthcare professionals were first informed in 1977 that sodium valproate could cause malformations in the babies of women who had been taking the drug during pregnancy.

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In recent years, studies had found about 10 per cent of babies exposed to the drug would have spina bifida, face and skull deformities or malformations of the limbs, heart, kidney, urinary tract and sexual organs.

About 40 per cent of children exposed to it were born with learning and behavioural problems.

Still, data showed, four Kiwi babies had been born with the disorder since 2017.

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Data provided by the Centre for Adverse Reaction Monitoring showed at least 29 babies had been adversely exposed to Epilim during pregnancy since 1978. Malformations were found in at least 24 of them while neurodevelopmental problems were reported for 13 children and five foetuses or infants died up until July 2017. Another two instances of the disorder had been confirmed since then.

Foetal Anti-Convulsant Syndrome NZ executive officer Denise Astill, centre, with twin daughters Jazmyn, left, and Natasha who were born with the disorder. Photo / Supplied
Foetal Anti-Convulsant Syndrome NZ executive officer Denise Astill, centre, with twin daughters Jazmyn, left, and Natasha who were born with the disorder. Photo / Supplied

While some other medications used to treat epilepsy and bipolar disorder could also pose a risk to unborn babies, it was higher with sodium valproate, Medsafe group manager Chris James said. The risk was present with low doses and increased with higher ones.

In 2016, sodium valproate was dispensed to 5082 women of child bearing age (15-49), according to data provided by Pharmac.

ACC has accepted treatment injury claims for 24 children with the disorder costing more than $6 million between when the first one was made in 2007/2008 and February 6 this year.

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Despite this week's change in policy, Foetal Anti-Convulsant Syndrome NZ executive officer Denise Astill believed the changes needed to be legislated so they became mandatory.

She claims none of the women she supported through Foetal Anti-Convulsant Syndrome NZ were fully informed about the risks posed by the medication when they were prescribed it.

Astill last year handed a petition to the health select committee at Parliament calling for an inquiry into the continued use of anti-epileptic medicines. She is still waiting for the committee to make a decision on her presentation.

Astill knows the affects of foetal anti-convulsant syndrome better than most. Her twin daughters, now 17, were born with it.

She was prescribed sodium valproate to manage her epilepsy and sought advice from two specialists prior to getting pregnant, specifically asking how the drug could affect her babies. She was told there was a risk of spina bifida or neural tube defects but that could be managed by taking folic acid.

"My girls don't have spina bifida or neural tube defects but they have a lot more than that," she said.

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Jazmyn and Natasha have a host of symptoms including auditory processing disorder, autistic tendencies, obsessive compulsive disorder, major anxiety, cognitive issues and epilepsy. They are slow to process information and have issues with their eyesight, bowels, speech language, heart, behaviour, attention and joints.

"We don't know what the future holds for them. We do know that to live independently they are going to need to be assisted and supported for the rest of their lives," she said.

"I had to give up my job. Everything in our lives changed. I'm not saying I regret having my children because I love my daughters, I'm so fortunate to have them. But their lives would look so much different if they had not been exposed to sodium valproate during pregnancy."

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