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