UK class action lawsuit over Sodium Valproate birth defects

[Bernard]

Sodium valproate is the chemical name for Epilim/Depakote:

Around 140 families who claim that their children were damaged by an epilepsy drug taken in pregnancy have begun a court action that they say could be "as big as thalidomide".

They say that 37,500 British children have "foetal anti-convulsant syndrome", a range of neural, behavioural and physical disorders, which they claim may have been caused by their mothers taking anti-convulsant drugs while pregnant.

Disorders include cleft palate and spina bifida, learning difficulties, behavioural problems and abnormalities in movement, speech, vision and hearing.

The court action applies specifically to the drug sodium valproate, which is only one of several anti-convulsant medicines. A trial date has been set for October 2008.

Many of the mothers were prescribed the brand-named product Epilim, made by Sanofi-Synthelabo. The drug was also available in unbranded generic forms. To date Sanofi is the only company involved in the action.

In order to gauge the scale of the litigation, the High Court has issued a cut-off date for families to apply to be put on the register of claimants.

David Body, of Irwin Mitchell, the solicitor handling the case, said it had 140 families registered but expected "some numbers" more.

The cut-off date for registration has been set for March next year but families need to contact lawyers by Oct 1 this year. Advertisements alerting families to the October date will be placed shortly.

...

"We want to hear from any family with a child with problems whose mother took any anti-epileptic drug in pregnancy," Mrs Williams said.

Action over epilepsy drug 'could rival thalidomide'

[Bernard]

Irish families are joining the action:

The drug has been prescribed to epilepsy sufferers in Ireland since the early 1980s. One of a number of Irish mothers who joined the proceedings last week was Paula Gusman, a mother-of-two from Mayo. She has been taking Epilim for more than 20 years, but was not aware of the risks.

“I have a daughter who has autism and a boy with behavioural problems,” said Gusman. “I was taking Epilim before and throughout both pregnancies. The only side-effects I was made aware of was the possibility of cleft palate. There was certainly no mention of behavioural problems and autism.”

Both of Gusman’s children were born healthy and, as in the case of many of what Williams calls “Epilim babies”, only diagnosed when they reached school age.

[Bernard]

20% !!!! :shock:

One in five women who took the widely used epilepsy drug valproate in a clinical trial had pregnancies resulting in birth defects or fetal death, researchers said Monday.

The drug, sold as Depakote by Abbott Laboratories Inc., was substantially riskier to unborn children than three competing medicines examined in the study. The researchers found cases of malformed hearts and genitals, cleft palate and artery deformities among children born to women taking the drug.

The report in the journal Neurology was the latest to document the potential dangers of valproate to fetuses. The drug is also used to treat headaches and some psychiatric conditions, including bipolar disorder.

...

The researchers, led by Dr. Kimford J. Meador of the University of Florida in Gainesville studied 333 pregnant women at 25 centers in the U.S. and England.

The women had been taking one of four drugs — valproate, carbamazepine, phenytoin or lamotrigine — when they became pregnant and continued use during their pregnancy.

Twenty percent, or 14, of the 69 women on valproate had pregnancies that resulted in fetal deaths or birth defects.

For phenytoin, which is sold as Dilantin, six of 56 women, or 11%, had pregnancies ending in fetal death or congenital malformations.

Nine of the 110 women who took carbamazepine (Tegretol), or 8%, had pregnancies that ended in fetal death or birth defects. The rate for lamotrigine (Lamictal), was 1% — one of 98 women on the drug.

Meador said the results showed that valproate should not be the drug of first choice for women of childbearing age.

But he added that it was less clear what the alternative should be.

He was reluctant to declare Lamictal the safest drug of the four because other studies had found a higher rate of birth defects associated with its use.

http*//www.latimes.com/news/nationworld/nation/la-sci-epilepsy8aug08,1,458006.story?ctrack=1&cset=true - Study Ties Epilepsy Drug to Fetal Risk

[Edit - LA Times story doesn't exist anymore, but the study that was referenced can be found here: In utero antiepileptic drug exposure]

[Vulcan558]

I know it is late but can someone tell me where we contact to register for this Court action. The reasons are as follows.
Our daughter Donna took Epilim (Valproate). Her first child died a matter of hours after birth. He had clef palet and spina bifida. Two years later she gave birth to Millie, who is now 16.

Donna had temporal right lobe and granmal epilepsy, which was virtually impossible to control. When she was young she would have up to 20 fits a day. All this started after the MMR jab, but that is another story. She took Epilim and Tegrotol.
We talk of Donna in the past tense. That is because she took her own life at 34 because she could not take any more of no quality of life. That's all we have to say about Donna. We, as grand-parents have been bringing up Millie since she was 2 years old.

Millie was born with hydrocephalus, Asthma, Fragile X (premutation, making her a carrier) and Sodium Vaproate Syndrome (assumed due to symptoms). It is almost certain this was caused by Valproate. She has moderate learning difficulties, does not like change, sits in the dark, has no sense of danger (she cannot cross a busy road even at 16). She has no friends at all, goes to a school for children with learning difficulties (Alfriston Girls School, Beaconsfield). She has a brilliant memory, excellent keyboard skills, difficult to understand due to speach problem.
Someone needs taking to task for causing this because it didn't happen by fluke alone. Let's hope something positive comes out of it.

[Bernard]

I updated the post with a direct link to Neurology

[RobinN]

I know it is late but can someone tell me where we contact to register for this Court action.

In order to gauge the scale of the litigation, the High Court has issued a cut-off date for families to apply to be put on the register of claimants.

David Body, of Irwin Mitchell, the solicitor handling the case, said it had 140 families registered but expected "some numbers" more.

The cut-off date for registration has been set for March next year but families need to contact lawyers by Oct 1 this year. Advertisements alerting families to the October date will be placed shortly.

22/05/2006 Date of article

[Bernard]

Epilepsy Drug May Increase Risk of Autism in Children


ST. PAUL, Minn. – A new study shows that women who take the epilepsy drug valproate while pregnant may significantly increase their child’s risk of developing autism. The preliminary research is published in the December 2, 2008, print issue of Neurology®, the medical journal of the American Academy of Neurology.

The ongoing study involves 632 children, nearly half of whom were exposed to epilepsy drugs during gestation. Of the children whose mothers took epilepsy drugs while pregnant, 64 were exposed to valproate, 44 to lamotrigine, 76 to carbamazepine and 65 to other epilepsy drugs. Of the 632 children in the study, nine have been diagnosed with autism and one has shown symptoms of the disorder. The children were tested at one, three and six years old. Two-thirds of the children were six years old by the end of the study.

The study found seven of the children with autism had mothers who took an epilepsy drug while pregnant, four of those children were exposed to valproate while a fifth child’s mother took a combination of valproate and lamotrigine. The children whose mothers were given valproate during pregnancy were seven times more likely to develop autism compared to children whose mothers did not take an epilepsy drug while pregnant. This risk was not seen with the other epilepsy drugs. None of the children in the study had any known family history of autism.

“The potential risk for autism in this study was substantial for children whose mothers took valproate while pregnant, but more research needs to be done since these are early findings,” says study author Gus Baker, PhD, FBPsS, of the University of Liverpool in the United Kingdom.“However, women who take valproate while pregnant should be informed of the possible risks of autism and are encouraged to discuss them with their doctor. Those who are taking valproate should not stop their treatment without speaking to their doctor first.”

Other studies have shown that valproate is more likely to cause birth defects than other epilepsy drugs.

Symptoms of autism include difficulty in language development, a lack of attention, social problems and the inability to understand other people’s feelings.

The study was conducted by the Liverpool and Manchester Neurodevelopment Group, a multidisciplinary group consisting of psychologists, geneticists, neurologists, midwives and support staff.

The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as multiple sclerosis, restless legs syndrome, Alzheimer’s disease, narcolepsy, and stroke.

Epilepsy Drug May Increase Risk of Autism in Children

[skillefer]

Let's face it....as my neurologist said, "There's no such thing as a safe anti-epileptic drug. They all have risks."

[drarvindr]

Agree with skillefer. The people in the suit should file one against their doctors for not telling them to come to them before planning a pregnancy or if they became pregnant. It is the duty of the neurologist to inform his patients that their babies are at risk. But even so , no drug is 100% safe. To go so far as to compare it to the thalidomide tragedy, i don't know. Epilim is relatively safe in pregnancy as long as you don't take it in the first trimester (which means the guy prescribing it to you should have told you it was unsafe in pregnancy and you needed folate supplements before you got pregnant). Once the neural tube is formed it's safe to use ( at least this is what the pharma guys would have us believe). I think the neurologists are the guiltier party in this equation , rather than valproate.

[skillefer]

Agree with the doc. When I got married, my doc asked if we were ever planning to have kids. At that time, I was on depakote and phenobarb and using depo provera for birth control. He had me quit the depo, weaned me off depakote, and had me start taking 800 mcg. of folic acid every day. That was 5 years ago. Now we're pregnant and he has me taking Dilantin. Once those levels are good, then I'll be weaned off the phenobarb. As Drarvind said, it's a matter of talking to your doctor.

[Junebug]

Agree with skillefer. The people in the suit should file one against their doctors for not telling them to come to them before planning a pregnancy or if they became pregnant. It is the duty of the neurologist to inform his patients that their babies are at risk. But even so , no drug is 100% safe. To go so far as to compare it to the thalidomide tragedy, i don't know. Epilim is relatively safe in pregnancy as long as you don't take it in the first trimester (which means the guy prescribing it to you should have told you it was unsafe in pregnancy and you needed folate supplements before you got pregnant). Once the neural tube is formed it's safe to use ( at least this is what the pharma guys would have us believe). I think the neurologists are the guiltier party in this equation , rather than valproate.

I agree with you 100%! My daughter was born with FACS from myself taking Depakote. I was told that the only risks in taking it while pg were Spina Bifida and cleft lip and palate. Both of my pregnancy's were planned, they had to be and I was prescribed 10x's the amnt of folic acid before getting pg, that is suggested by a woman who is not high risk.
After I had my daughter I had an appt with my neurologist. and told him about my daughter, he claimed that he had NEVER heard about FACS. ARE YOU KIDDING ME? He had me register with the anti-epileptic drug preg. registery and he's never heard of it? What a LIAR!
My daughter has MANY med problems, she was way under a normal birthweight, (4 lbs 5 oz at 37 wks) had a hole in her heart, had a high soft palate which was prob from a cleft palate that barely closed in time, she had to have a feeding tube, she has very small fingers, toes, ears, eyes, nose, mouth, couldn't walk till she was 3, (she just turned 4 in Sept.) She has a huge developmental and speech delay among other things but ya know what? I wouldn't trade her for anything and if I were among one of those families who were included in the class action law suit and actually won, I would donate most of the $ to epilepsy research.
I'd put a small portion of $ in savings for my own Rx costs! LOL!

[Bee91]

I read this today...But isn't this one of the meds you aren't supposed to take while pregnant anyway?

[skillefer]

Which one depakote? Yes, you aren't supposed to take it while pregnant. But the question is, how many doctor's tell their patients that?

[Junebug]

I read this today...But isn't this one of the meds you aren't supposed to take while pregnant anyway?

Technically, none of the meds are safe. My dr only said that Spina Bifida and Cleft lip/palate were the only birth defects I had to worry about with Depakote.

[Bee91]

I thought I heard that Lamictal was pretty safe to use while pregnant...

well...one of the safest you can get compared to the rest of them.

[Bernard]

... The people in the suit should file one against their doctors ...

... My dr only said that Spina Bifida and Cleft lip/palate were the only birth defects I had to worry about with Depakote.

That's the crux of the problem. Doctors were not informed of the risks for autism from valproate.

I thought I heard that Lamictal was pretty safe to use while pregnant...

It was widely touted that way before studies showed increased risks for cleft palate/cleft lip.

[Junebug]

That's the crux of the problem. Doctors were not informed of the risks for autism from valproate.

No autism diagnosis for my daughter, just a lot of developmental delays. Last testing she had with her occupational therapist was in November and she tested at 21 mo old. She's 51 mo. this next monday.
She has to "teach" her body to do normal everyday things that are nearly impossible. Her fingers for example, are so tiny and stiff that she shouldn't be able to do a pincher grasp much less make a fist but she learned how to do that.
Dr's knew that Depakote causes developmental delays and developmental disability, autism is a deveopmental disability/delay so they knew, they just had to do their studies that they do for years on end before they can document the findings.

[drarvindr]

Hmmm... difficult question . As far as using the drug during pregnancy goes , most doctors ( and i am agreed) feel that the risk of a seizure during pregnancy to the baby far outweighs the risk of teratogenic anti epileptic drugs. But it's a delicate equation and requires more study. Drug development has not given us a safe anti-epileptic drug as yet , but the risks need to be conveyed to the patient.

[Junebug]

Hmmm... difficult question . As far as using the drug during pregnancy goes , most doctors ( and i am agreed) feel that the risk of a seizure during pregnancy to the baby far outweighs the risk of teratogenic anti epileptic drugs. But it's a delicate equation and requires more study. Drug development has not given us a safe anti-epileptic drug as yet , but the risks need to be conveyed to the patient.

How do you figure this? I've heard this many, many times but there are many kinds of seizures, absance seizures don't cause a lack of O2 to the brain, myoclonic seizures don't gen. partials don't and unless there is complete unconsciousness any lack of O2 is very miniscule.
I took all precautions that my neurologist told me when I was pg, I was allowed to drive because I only had nocturnal seizures and they were during my cycles but I stopped driving alltogether because hormones are different during pgncy.

Ya know the ironic thing about this whole thing is that I had many noctornal seizures where I lost consciousness when pg with my oldest daughter (7 yrs) when I was also taking depakote but when I was on depakote with my youngest daughter (4 yrs) my seizures were controlled and did not have any seizures for 18 mon, from the time we started trying to get pg - up until I gave birth, and she's the one with the FACS from the depakote.

[Bernard]

... most doctors ( and i am agreed) feel that the risk of a seizure during pregnancy to the baby far outweighs the risk of teratogenic anti epileptic drugs. ...

Are you aware of any studies giving some scientific basis for this feeling/belief? Just curious because my wife was completely uncontrolled with her seizure activity with child #2 (she was taking Depakote after the first trimester, but it didn't help). She was having tonic clonics about once a week or so. I was very worried about the possibility that lack of oxygen might cause brain damage to the child, but even with weekly tonic clonics all through the pregnancy, he turned out sharp as a tack.

I know a sample of one is hardly a basis for establishing anything, but I wonder if our child was just miraculously lucky or if the fear/risks of seizures during preganacy are overblown. It would be interesting to see some real numbers on the risks with anti-epileptic drugs versus without.