Canada : Women on epilepsy drug say they weren’t warned of birth defect risk

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A drug commonly used to treat epilepsy has been linked to serious birth defects — a side-effect that some Canadian mothers say they weren’t properly warned about while pregnant.

Nicole Vahle of St. Catharines, Ont., was prescribed a medication containing valproic acid while she was pregnant. When her daughter Savannah was born, she was diagnosed with fetal valproate syndrome, a condition that delayed her ability to walk, talk and smile.

“She didn’t really move much, she couldn’t even move most of one side of her body,” Vahle told CTV News.

Countries such as France and the U.K. have recently issued strong warnings about pregnant women taking valproic acid. But Vahle says that she was given no such forewarning from her doctor.

“I was very depressed about it. It was upsetting, not having your daughter smile while everybody else’s kids around that age are smiling,” she said.

Health Canada issued a public advisory about valproic acid five years ago, saying that birth defects are “a rare but well known risk associated with their use.” The agency also referenced studies that found children whose mothers took a valproate drug generally scored lower on cognitive tests.

While that information can be easily found online, some mothers say the Canadian government and doctors aren’t doing enough to directly communicate the serious risk.

Noreen Spagnol took valproic acid for her epilepsy, and both her daughters, now aged nine and seven, were born with birth defects.

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“He didn’t tell me, you know, ‘Do you want to try another medication? Do you want to look more into what the side-effects are?’ He didn’t give me any of those options,” Spagnol said.

But the decision to discontinue the treatment for expectant mothers is fraught. Going off the drug can be a difficult choice, as substitute medications may not work as well — if at all — and a seizure during pregnancy can carry a risk of death for both mother and baby.

Spagnol said she should’ve been told of the “true risks” of being on the medication.

“I had so many other options I didn’t know about and all my neurologist made me think was, you have to stay on this medication, because if you’re off, you’ll have a seizure and that’s too big a risk. That’s not the only option,” she said.

Regardless, women taking the drug should have all the necessary information before they become pregnant, according to one Canadian patient advocate.

“So it is a significant concern that not just neurologists but also all doctors who are prescribing these medications do need to be aware of this,” said Dr. Esther Bui, a neurologist with Toronto Western Hospital.

Spagnol said she hopes that by sharing her story, she’ll be able to reach women who aren’t aware of the birth defect link.

“I would like to let other women know that it is very important to fully educate yourself as much as you can,” she said. “I thought I had, to be honest.”

According to figures from Statistics Canada, an estimated 139,200 Canadians are diagnosed with epilepsy, and more than 50 million people live with the chronic neurological condition worldwide. Epilepsy may be passed on genetically or the side-effect of a variety of conditions, such as a brain tumour, stroke, head injury, or lack of oxygen.

 

Lamotrigine Use ‘May Decrease Efficacy Of Ketogenic Diet’

A child taking a tablet. Ref: www.dreamstime.com

Children with epilepsy who are consuming a ketogenic diet may not benefit from the use of the antiepileptic drug (AED) lamotrigine, according to a new study.

Conducted by the Erasmus University Hospital Sophia Children’s Hospital and published in the medical journal Seizure, the purpose of the research was to elucidate relationships between efficacy of the ketogenic diet and use of specific AEDs.

The ketogenic diet is a high-fat, adequate-protein, low-carbohydrate diet that has been shown to be effective in aiding seizure control. They are often used at the same time as AEDs, but it has been hypothesised that certain drugs may interfere with the diet.

A retrospective study was performed in 71 children with refractory epilepsy starting the diet between 2008 and 2014 at the hospital, with the efficacy of the ketogenic diet evaluated after three months of treatment and analysed alongside the AEDs used.

It was shown that the diet was successful after three months in 61 per cent of the children, but the efficacy was significantly reduced if children used lamotrigine at diet initiation or during the course of the regime.

In comparison to children using other AEDs, the percentage of children that experienced a benefit from the diet was significantly reduced in case of lamotrigine use, showing the impact was specific to this therapy.

 

http://www.epilepsyresearch.org.uk/lamotrigine-use-may-decrease-efficacy-of-ketogenic-diet/

Potential new class of antiepileptic drugs discovered

A picture of a hyperexcitable neuron. Ref: www.dreamstime.com

US scientists have discovered a biological process that could form the basis of a new class of antiepileptic drug (AED) therapies.

The team, based at Duke University, has identified a potential new class of drugs that in the future could help to prevent the development of temporal lobe epilepsy – one of the most common and damaging forms of the condition.

This research builds on the previous understanding that a brain protein called TrkB, which is important for the development and survival of different types of brain cell, becomes overactive after an episode of prolonged seizures. Scientists wondered if this increased activity played a role in turning a one-time seizure ‘event’ into a chronic disorder. This thinking was later supported by the results of a 2013 study,which showed that blocking TrkB signalling in a rodent after an episode of prolonged seizures prevented the later development of epilepsy.

However, inhibiting TrkB completely in this way caused a number of undesirable side effects, because its actions are very broad. This new study, published in the medical journal Neuron, aimed to highlight the specific TrkB-dependent  mechanisms that lead to chronic seizures and develop a drug that blocks only this pathway.

The drug the group identified is called pY816, and it acts by preventing TrkB from combining with and activating another protein called phospholipase Cγ1. The researchers found that giving pY816 to rodents for just three days after an episode of prolonged seizures reduced both the likelihood and severity of epilepsy many weeks later.

Efforts will now be made to increase our understanding of how pY816 works, before (hopefully) progressing it clinical trials.

Dr James McNamara, a professor in the departments of neurobiology and neurology at Duke University, said: “What we hope is that we could use this drug to intervene in patients who have had an episode of prolonged seizures and give it to them briefly following that episode to protect them from [developing epilepsy].”

Mothers demand an end to epilepsy drug ‘cover-up’

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Oct
2015
Thursday 29th
posted by Faye Lipson in Britain

Women tell doctors to warn patients of its pregnancy effects


MOTHERS who gave birth to disabled children after taking a controversial epilepsy medication met MPs yesterday in a bid to expose a “huge cover-up” around the drug.

Campaigning group Infact wants to force doctors to tell their patients about the high-risk that sodium valproate — better known by brand name Epilim — poses to foetuses.

A huge 40 per cent of children born to mothers taking the drug have neurodevelopmental disorders such as autism.

And 11 per cent are born with major physical malformations such as spina bifida and heart and kidney problems.

Infact is also urging Health Secretary Jeremy Hunt to launch an independent inquiry.

It has learnt that doctors were advised by the now defunct Committee on Safety of Medicines not to tell patients of the drug’s dangers when it was first issued for prescriptions in 1973.

This advice is no longer in force, although Infact alleges that most women prescribed the drug are still not being told of its risks.

Group co-founder Janet Williams told the Star: “So many kids have been harmed by this drug.

“We have got to make it mandatory for the doctors to tell ladies of the risks and give them that informed choice to make for themselves. At the moment, that is just not happening.”

Mother-of-two Catherine Cox, who provides educational support to children affected by foetal anticonvulsant syndrome (FACS), had a child with the condition while taking sodium valproate.

Her second child, born while she was taking a different anticonvulsant drug, does not have FACS.

“It’s been swept under the carpet all the way along,” said Ms Cox. “I asked very, very clear questions [before becoming pregnant] and was told that if my baby had cleft palate it would be unlucky, but they’d be able to sort it. And that was all I was told.”

Emma Murphy, who co-founded Infact with Ms Williams, has five children — all with FACS.

She warned that the drug was now being given out in high doses for conditions such as bipolar disorder.

“They know that it will harm the babies. Women should be told,” said Ms Murphy. “I went through five pregnancies and was told nothing.”

Labour MP Teresa Pearce agreed at the meeting to collate personal stories from victims of Epilim and send them to Mr Hunt in order to put “evidence-based pressure” on him to launch an inquiry.

23rd October – Sudep Awareness Day

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For the majority of people diagnosed with Epilepsy, SUDEP is a huge worry and fear. It certainly is for me. The thought of dying due to my epilepsy absolutely petrifies me so on SUDEP Awareness Day what better day to educate and keep the awareness of this going.

Before you read the facts, here are 2 stories of how SUDEP claimed the lives unexpectedly of loved ones.

Mark : My story is about my friend Julie Hamilton. She had just finished a course of therapy, her anxiety was so high at one point she could not leave her house. She gradually managed to adhere to the Neuropsychologist’s advice and ended up being able to do a day trip to Edinburgh Castle. A huge milestone for her.

All this aside, her Epilepsy was not controlled despite having brain surgery in 1998. She required on-going support from carers and home alarm systems. Despite her positive and fiery attitude to life, she passed to SUDEP on 28 November 2012, suffocating on a carrier bag after a violent grand mal seizure. She always reminded me of Dougal from Father Ted, always had me laughing

Tonianne : We lost our sister Samantha Jane to SUDEP 7 years ago. She’s was 19 year old and left a 1 year old baby behind .
She decided that having a bath was the perfect idea , And has she climbed in. She had a seizure
She slipped and banged her head on the bath with such force it chipped the bath and her teeth she somehow sat up before going unconscious and fell backwards into the water has a result she drowned and passed away.

We always value her life and remember her has a happy, confident sarcastic, A good loving mum and a great sister and daughter.

Who liked to do anything without letting her illness bog her down.

 

What Is SUDEP?

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Sudden Unexpected Death in Epilepsy (SUDEP) is the term used when a person with epilepsy dies without warning and where the post-mortem fails to establish any other cause of death.
For some people living with epilepsy, the risk of Sudden Unexpected Death in Epilepsy (SUDEP) is an important concern. SUDEP refers to deaths in people with epilepsy that are not caused by injury, drowning, or other known causes.1 Studies suggest that each year there are about 1.16 cases of SUDEP for every 1,000 people with epilepsy, although estimates vary.

Risk factors for SUDEP
• Uncontrolled or frequent seizures
• Generalized convulsive (also called tonic-clonic or grand mal) seizures1
• Seizures that begin at a young age.
• Many years of living with epilepsy.
• Missed doses of medicine.
• Drinking alcohol.

 

Steps to reduce the risk of SUDEP

If you have epilepsy, ask your doctor to discuss the risk of SUDEP with you.
The first and most important step to reduce your risk of SUDEP is to take your seizure medicine as prescribed.
Other possible steps to reduce the risk of SUDEP may include
• Avoid seizure triggers, if these are known.
• Avoid drinking too much alcohol.
• Learn how to better control your seizures with epilepsy self-management programs.
• Get enough sleep.
• Train adults in the house in seizure first aid.

e0bba9cd03b8183fe1cb00dda46b0d5dThank you to Mark and ToniAnne for sharing your stories

Long Term Seizure Outcomes “Excellent for childhood onset epilepsy”

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A new study from Finland has indicated that childhood-onset epilepsy patients generally experience positive seizure outcomes in the long term.

The University of Turku-led research, published in the medical journal Epilepsia, also noted that patients remain at risk for a number of health conditions in later life, suggesting these trends should be closely monitored.

A population-based cohort of 245 subjects with childhood-onset epilepsy was assessed for outcomes at 45 years in order to study the impact of epilepsy on a variety of health outcomes across the lifespan of these patients.

In addition, 51 of 78 surviving subjects with uncomplicated epilepsy and 52 of 99 originally matched controls went on to participate in a more detailed evaluation that included electroencephalography, imaging and laboratory studies at 50 years.

Of the 179 surviving subjects, 61 per cent were found to be in terminal ten-year remission, with 43 per cent achieving this seizure freedom without any further need for medication.

At 45 years, 95 per cent of those with idiopathic epilepsy were in terminal remission, as well as 72 per cent of the cryptogenic group and 47 per cent of the remote symptomatic group.

Abnormal neurologic signs were shown to be significantly more common in subjects with uncomplicated epilepsy than in controls, while mortality rates were also higher among those with epilepsy.

MRI scans also revealed more abnormalities among childhood-onset epilepsy patients, specifically when examining markers of cerebrovascular disease. This was even the case in idiopathic epilepsy patients, the vast majority of whom had achieved seizure freedom.

The researchers concluded: “Long-term seizure outcomes are excellent and a function of etiology. The presence of imaging abnormalities suggestive of vascular disease may put these subjects at higher risk for clinically evident stroke and cognitive changes as they age.”

 

Epilepsy Research