Epilim: Hundreds of babies exposed to medicine known to cause birth defects
Hundreds, if not thousands, of unborn babies have been exposed to a medicine known to cause serious birth defects. Officials are accused of being too slow in reacting to the threat. Blair Ensor reports.
Heather Campbell couldn't get out of bed without having a seizure.
The then 23-year-old had been prescribed an array of different medications to control her epilepsy, but none were particularly successful.
The debilitating seizures meant she couldn't ride a bike, let alone drive a car, and her job opportunities were limited.
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That was until a neurologist prescribed her Epilim, also known as sodium valproate.
Within a matter of weeks, the anti-epileptic medicine had all but stopped her seizures.
"It was life-changing. I suddenly became independent – it was like my world just opened up," she says.
Several years later, in about 1992, Campbell and her partner sought advice from a Wellington neurologist about having a baby. She'd read in a women's magazine that Epilim could be harmful to the foetus, but the doctor said that was a "load of rubbish" and the medication was safe to use while pregnant.
"Go forth and multiply," he told them.
Within five years Campbell had given birth to two children.
Jackson, now 25, is on the autistic spectrum, is cognitively impaired and only recently overcame a speech impediment. He will never drive a car, is unlikely to attend university and will require support for the rest of his life.
Trudy's heart did not form properly while in the womb. She died within seconds of being born.
Experts have linked Jackson's disabilities to Epilim exposure, diagnosing him with Foetal Valproate Syndrome. He receives tens of thousands of dollars in compensation from the Accident Compensation Corporation (ACC) each year.
Campbell believes the medication is also to blame for her daughter's death. She has no documents to prove that, but says an expert told her it was the likely cause.
"Epilim is a wonder drug for me ... but look what it's done to my children – it's taken a life," she says.
HUNDREDS OF CHILDREN EXPOSED
Campbell's story isn't an isolated one.
Epilim, which is manufactured by pharmaceutical giant Sanofi, has been available in New Zealand for more than 40 years.
It is regarded as the most effective treatment for epilepsy and is also widely prescribed to those with bipolar disorder.
For many years there has been evidence the medicine could cause birth defects such as spina bifida, cleft palate or malformed limbs and organs.
Despite that, it's been prescribed to hundreds, if not thousands, of pregnant women.
Some claim they were not fully informed of the dangers.
In 2005, Medsafe, the country's medicines regulator, warned health professionals that Epilim should not be used in pregnancy unless there was no alternative.
More than 820 babies have been exposed to the medication since then, but the numbers have steadily declined year on year, according to the Ministry of Health.
ACC says "the reduction in prescriptions for women of child-bearing age is less than hoped". Since 2007, it has paid more than $6.3 million to 27 people living with Foetal Valproate Syndrome.
The number of females, aged 15-49, dispensed Epilim fell from 5613 in 2014 to 4590 in 2018, according to Pharmac.
It's not known how many unborn babies exposed to the medication in New Zealand have been harmed. The Centre for Adverse Reactions Monitoring has been alerted to 33 cases, including five deaths, since 1978, but reporting is voluntary.
In the United Kingdom, where the prescribing of Epilim has been called an "extraordinary scandal", it's estimated more than 20,000 have been affected.
Medsafe says the risk appears to be dose-dependent.
According to its website, research has shown about 10 per cent of children exposed to Epilim will have a birth defect and up to 40 per cent will have learning and behavioural problems like delays in learning to walk and talk, lower intelligence, poor speech and language skills and memory problems.
The regulator updated its guidelines in March, advising that the medicine should not be used in women of "child-bearing potential" unless all other treatments are "ineffective or not tolerated".
Foetal Anti-Convulsant Syndrome New Zealand (FACSNZ), an organisation that's campaigned for tougher regulations around Epilim's use, says officials have been slow to react to the threat, which it believes is the "equivalent of the thalidomide disaster". Thalidomide was prescribed to women for morning sickness in the 1960s and thousands of babies worldwide were born with severe deformities.
The organisation wants an inquiry into the prescribing of anti-epileptic medicines during pregnancy.
A CAMPAIGN FOR CHANGE
Denise Astill, 44, always wanted children, but never thought she'd have to give up her teaching career to care for them well into their teens.
Astill was diagnosed with epilepsy at the age of 16 after she had a seizure and became unconscious in the bath.
Epilim was the first medication she was prescribed.
She and her husband, Cameron, sought advice from a neurologist and a maternal medicine specialist before getting pregnant.
The neurologist, Astill says, told her that there was an increased risk her baby could be born with spina bifida or neural tube defects if she continued taking Epilim, but everything would be "absolutely" fine if she took folic acid for the duration of her pregnancy. (If she came off Epilim she risked having a seizure that could starve the foetus of oxygen and cause brain damage.)
The maternal medicine specialist supported that advice, she says.
When she eventually fell pregnant scans revealed twins.
Natasha and Jazmyn were born premature at 34 weeks on October 19, 2001. Astill was 26 at the time.
There were problems right from birth – the pair had difficulty breathing and struggled to feed and Natasha's face looked a "bit different" – but it was four and a half years until they were diagnosed with Foetal Valproate Syndrome.
"The grief and guilt I went through was horrendous because I blamed myself for what had happened. All you want is for your children to be healthy .. and unfortunately my girls were not. It took me a while to come to terms with the fact it was the medicine and not me that did this."
Now 17, they both have developmental and physical problems and will need support for the rest of their lives.
Natasha is arguably worse-affected. She can't cross a road by herself and needs a support person to use public transport.
The pair were among the first accepted for ACC cover in 2008.
In 2013, Astill lodged a complaint with the Health and Disability Commissioner about the standard of care she received before getting pregnant.
In her decision, then deputy commissioner Theo Baker said while she was "sympathetic" to her concerns around inadequate advice, "it is not practicable for me to examine this complaint further after such an extended time period of time has elapsed". Baker noted that Medsafe appeared to provide extensive information to healthcare professionals about the risks associated with taking Epilim during pregnancy. No further action was taken.
Astill says she was "thoroughly disappointed" with the outcome – not because she wanted someone held accountable, but rather "I wanted systemic changes to occur".
"We are now six years down the track and babies and children are still being harmed as a result of inaction from governmental bodies in ensuring that all healthcare professionals are aware and educated of the risks."
In 2015, Astill established FACSNZ, a not-for-profit organisation dedicated to raising awareness about the risks associated with taking anticonvulsants, like Epilim, during pregnancy.
The organisation, which supports about 50 families in Australia and New Zealand, is "focused on prevention" because "every single person I'm in touch with did not know the full risks", she says.
Some families have three children suffering from conditions related to Epilim exposure.
Astill has lobbied the likes of Medsafe pushing for changes to the way the medicine is dispensed and prescribed in New Zealand. In many instances, she says, informed choice and informed consent is lacking.
In her view, change has been slow in coming.
Last year she presented the Government's health select committee with a petition calling for an inquiry into the prescribing of anti-epileptic medications, like Epilim, to pregnant women.
Astill says the March alert from Medsafe, which advised against Epilim use in women of child-bearing potential, is a step in the right direction, but it needs to be mandated to ensure the message is getting through to medical practitioners.
She points to the case of Hope Plews, a Taranaki woman who was prescribed Epilim in December and then fell pregnant. Two days after Medsafe's alert, Plews says she sought advice from an obstetrician and was told the medicine posed minimal risk to her unborn child. Her own research revealed that wasn't the case and she's concerned that when her baby is born it will have been harmed. Plews has lodged a complaint with the Health and Disability Commissioner about the standard of care she received.
"Cases like that shouldn't be happening," Astill says.
On 17 occasions, she's asked to meet with Health Minister David Clark to discuss the issue. Each time he's declined.
A spokesman for the minister recently told Stuff his "tight schedule means that unfortunately he is seldom able to accept such requests".
Astill and FACSNZ chair Jacki Morris recently travelled to Europe where they met officials from the World Health Organisation and campaigners and politicians instrumental in recent changes to the prescribing of Epilim in the United Kingdom.
AN 'EXTRAORDINARY SCANDAL'
British Liberal Democrat MP Sir Norman Lamb, who was a health minister in the Coalition Government from 2012-2015, believes Clark has a "moral obligation" to meet with Astill and other campaigners.
"There are children being born with all sorts of developmental issues ... all sorts of life-changing impacts and the health minister refuses to be the lead campaigner? That's just extraordinary. I don't think he can sustain that position and I would hope very much that there would be a rapid rethinking ... and a willingness to meet without delay."
Lamb says that despite a growing knowledge in the UK among officials about the risks associated with the use of Epilim in pregnancy there was, for many years, a "conspiracy of silence".
He only became aware of the issue, which he's called an "extraordinary scandal", when he met with a group similar to FACSNZ, which was campaigning for change.
"I was so horrified by what I heard ... that I embarked on a review."
That review, he says, ultimately led to the UK's medicines regulator last year banning the prescribing of Epilim to women of child-bearing potential unless they have enrolled in a pregnancy prevention programme and signed a risk acknowledgement form.
Lamb, who met Astill and Morris on their recent trip, says New Zealand's situation is "inevitably very similar to the experience we've had". Kiwi officials appear to be lagging behind in terms of their "reaction and response", he says.
"Obviously the problem is less significant in terms of numbers ... but it's still children being born with life-changing issues and for that there needs to be a response."
Despite the recent changes in the UK, Lamb says "significant" numbers of women are still being prescribed Epilim during child-bearing years without proper advice, but "we're on the journey to getting it cracked".
"What has to end is simply women taking this without the necessary information to make a proper judgment."
In a letter to Astill in April, World Health Organisation (WHO) assistant director-general Dr Mariangela Simao expressed "deep concern" at the "preventable harm" children continued to suffer from products like Epilim.
"As is seen with this and other products, knowledge does not always lead to safer medicines or good practices."
Astill says she met with Simao and some of her colleagues in Geneva in July. At that meeting, she says, it was agreed that the WHO would work collaboratively with FACSNZ and its UK equivalent to raise awareness of the risks of taking Epilim while pregnant.
Numerous initiatives were discussed, including the establishment of pregnancy registers in New Zealand and the UK so the medicine's adverse affects could be better monitored.
"It was a very positive meeting and we feel very encouraged that there will be change."
INFORMATION GAP 'NEEDS TO CLOSE QUICKLY'
National MP Michael Woodhouse was on the select committee that heard Astill's petition last year and says he was surprised to learn how many women of child-bearing age in New Zealand were taking anti-epileptic medications, like Epilim, given "the exposure risk is very high".
There appears to be an "information gap" between what women know about the dangers associated with taking the drug and the "real risk", he says, and "that needs to close quite quickly".
In Woodhouse's view, the number of people harmed by anticonvulsant drugs is significantly under-reported in New Zealand.
The select committee is still considering Astill's petition – it only recently received information from the Ministry of Health – but he expects that at the very least it will result in "strong recommendations" to ensure medical professionals and patients are better informed about the dangers of Epilim.
Despite historic cases where women claimed to have been misinformed by neurologists prescribing the drug, Auckland-based neurologist Dr Elizabeth Walker says people in her field of expertise are well aware of the risk Epilim poses to the foetus. The same might not be the case for general practitioners "who get bombarded with all sorts of stuff".
It's "almost certain" there are still cases falling through the cracks. Young people who have unplanned pregnancies are particularly susceptible, she says.
"The symptoms that respond really well to this drug often start in childhood and early teens. Paediatricians don't often talk to girls about not getting pregnant because they have a different mindset."
Health practitioners should be thinking about the age of those they're prescribing the drug to and talking to them about the importance of contraception, even if that means a difficult conversation with a 12- or 13-year-old.
Walker sits on the committee for the Australian Pregnancy Register, a voluntary register of women in Australia who become pregnant while taking anti-epileptic medication. Last year there were no abnormalities in pregnancy arising from Epilim use. No such register exists in New Zealand, she says.
Medsafe general manager Chris James says Medsafe has taken "a lot of action" to restrict Epilim's use and provide up-to-date information to medical professionals.
However, there are "really important questions", he says, around whether health professionals are taking note of the information they're provided, and secondly, whether a patient's expectations of informed consent align with those prescribing the medicine.
Under the Health Practitioners Competence Assurance Act and the Code of Health and Disability Services Consumers' Rights medical practitioners are expected to provide patients with the information to make informed choices, effectively mandating Medsafe's guidelines, James says.
There's no legislated requirement for a company like Sanofi to provide an information leaflet to consumers with their medication and "that's something we believe is a gap", he says. It's hoped that will be addressed as part of the proposed Therapeutic Products Bill.
A spokesman for the Medical Council of New Zealand, which is responsible for reviewing the conduct of doctors, says it has not received any complaints about the prescribing of sodium valproate to women of child-bearing potential.
Doctors are expected to ensure patients are fully informed and consent to treatment, the spokesman says. Any concerns about the standard of care provided by a doctor can be raised with both the Health and Disability Commissioner (HDC) or the council, he says.
A Sanofi spokeswoman says the pharmaceutical company works with Medsafe to ensure the latest and most up-to-date information about Epilim is publicly available. The company produces an education booklet, the spokeswoman says, and writes to all healthcare professionals annually to ensure they're aware of its content. Sanofi's local website highlights the risk of taking the medicine while pregnant and it's exploring the potential for a warning symbol on the blister packs, she says.
"We are committed to patient health and safety and have treated these matters with the highest degree of importance."
A LIFETIME OF GUILT
Heather Campbell was 32 weeks pregnant when she learned Trudy, the daughter she'd yet to meet, had a rare heart condition (it hadn't formed properly) and would die within seconds of birth without surgery. If the operation was successful it was unlikely her baby would live beyond the age of 10.
Campbell decided against trying to prolong her daughter's life.
"All I could think was 'how am I going to sit down with my child and tell them they're going to die?' and I didn't want to have to do that."
She was induced six weeks later, in October 1996, largely for her own sanity.
"It was so hard to face. Having her induced was almost like killing her, but I had to be quite matter of fact and accept the birth process was part of it."
Trudy, as predicted, survived for only a fleeting moment. She moved a little, but didn't breathe.
Several weeks later, Campbell clutched a cannister of film as she walked to a shop to develop some photos.
"That was all I had left of her."
Experts later told her that Trudy, whose ashes she keeps in a light blue ceramic teddy bear urn, was severely impacted by the Epilim to which she'd been exposed. She had many physical symptoms.
Since then Campbell, who works as a social worker for the Northland District Health Board, has dedicated much of her life to caring for her son.
Jackson had issues at birth – he had low muscle tone, struggled to feed and missed all his milestones – but it wasn't until his early teens that he was diagnosed with Foetal Valproate Syndrome.
"It's really hard work raising a child that's damaged by valproate ... they're not your normal baby – everything is difficult."
Campbell says that if she had her time again, knowing what she knows now, she would have continued using Epilim, but wouldn't have had children.
"I don't even have to second-guess that. And that's got no reflection on the love I have for my son, Jackson.
"The guilt is overwhelming. I feel like personally I have harmed my babies and that guilt doesn't go away."
WARNING: No-one should stop taking Epilim, also known as sodium valproate, without first discussing it with their doctor. To do so without proper advice could result in serious harm, Medsafe says.
- Additional reporting by Hannah Martin.