Valproate Drug Harms : EMA Public Hearing in London

Many pregnant women are still unaware of epilepsy drug risks

The public hearing was part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.

Warnings to young women who might become pregnant that the epilepsy drug sodium valproate could cause birth defects and developmental problems in their babies could have been made public more than 40 years ago, according to campaigners.

EMA Public Hearing about Drug Valproate Use in Pregnancy

Pregnant women still unaware of epilepsy drug risks

Was there a deliberate decision not to publish Valproate’s risks ?

The public hearing was part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.

Warnings to young women who might become pregnant that the epilepsy drug sodium valproate could cause birth defects and developmental problems in their babies could have been made public more than 40 years ago, according to campaigners.

20,000 Children harmed by Epilim antiEpileptic Drug in the UK

Approximately 40 per cent of the 48,000 children born in the UK to mothers taking Epilim since it was introduced in 1973 have developed either mental or physical disorders, with many suffering both

Epilepsy Research UK logo
1 in 103 people in the UK live with epilepsy. @EpilepsyRUK fund groundbreaking research into the causes, treatment and prevention of epilepsy.

Approximately 40 per cent of the 48,000 children born in the UK to mothers taking Epilim since it was introduced in 1973 have developed either mental or physical disorders, with many suffering both.

That is according to the Daily Mail, which states that drug is now being blamed for causing more harm to children than Thalidomide.

Epilim is one of the registered trade names for sodium valproate, which has been at the centre of a media storm in recent weeks following the publication of new research into its effects on unborn children and a special BBC documentary.

The anti-epileptic drug controls electrical activity in the brain and is one of the most effective means of halting seizures.

However, Emma Murphy, founder of the Independent Fetal Anti-Cunvulsant Trust, told the news provider: “This is bigger than Thalidomide and it will not just be epileptic mothers whose babies are harmed. Epilim is prescribed to pregnant mothers with depression, bi-polar disorders and even for pain relief.”

Sources:
  • Nearly 20,000 Children Harmed By Epilim (Sodium Valproate), EpilepsyResearchUK, News, Feb 26 2013.
  • The drug that’s harmed more children than Thalidomide, DailyMail, article-2284425, 26 February 2013.

Grunenthal and Sanofi Pharmaceutical Companies must face their obligations – 38 Degrees Petition

DRUG JUSTICE – PHARMACEUTICAL COMPANIES SHOULD PAY FOR THEIR MISTAKES

British thalidomider logo image
Campaigning to have Grunenthal and Sanofi face their obligations and to stop hiding behind the protection of European legislation, face their responsibility and their guilt, and pay adequate compensation to the thousands of victims affected by their #drugs.

We are campaigning to have Grunenthal and Sanofi face their obligations and to stop hiding behind the protection of European legislation, face their responsibility and their guilt, and pay adequate compensation to the thousands of victims affected by their drugs.

The drug thalidomide – marketed for pregnant women suffering with morning sickness – was invented and sold by a German pharmaceutical company called Grunenthal between 1957 and 1961. Thalidomide killed most babies in the womb and those who survived are severely injured and disabled. The drug Epilim (Sodium Valproate) was marketed in 1973 as a drug for Epilepsy and to date has affected approx. 20,000 babies in a similar disastrous way.

Grunenthal has never compensated any British thalidomider. We ask that Grunenthal face their responsibility and give financial compensation to thalidomide damaged people in the UK. Grunenthal’s CEO must sit down with the thalidomide representatives and discuss financial compensation not just for the suffering and pain of living with thalidomide but also for the ongoing extra costs of living with the pain caused by thalidomide “.

Read TO: GRUNENTHAL AND SANOFI – DRUG JUSTICE – PHARMACEUTICAL COMPANIES SHOULD PAY FOR THEIR MISTAKES, 38degrees.org.uk/petitions/
a Campaign created by Mikey Argy – SIGN THE PETITION.

Sodium Valproate: the Cost…

Learn more about sodium valproate AEDs side-effects

truth is what you intuitively believe to be so…
not what I tell you

  • Video by APESAC, Published on 14 Feb 2014
  • This film uses the failed fetal anti-convulsant litigation against a multinational pharmaceutical company to critique UK law, and medicine regulation. It further addresses the economic effects of this failed litigation, and questions decisions within government regarding spending cuts within the public sector—particularly the legal aid budget. Is austerity the answer? Do short-term savings result in long-term costs?

More info and Videos

 

Exposure to AntiEpileptic Drugs in Utero and Child Development

Prospective population-based study, 2013

Abstract

Exposure to antiepileptic drugs in utero and child development: a prospective population-based study
Exposure to antiepileptic drugs during pregnancy is associated with adverse development at 18 and 36 months of age, measured as low scores within key developmental domains rated by mothers

PURPOSE:
Antiepileptic drugs may cause congenital malformations. Less is known about the effect on development in infancy and childhood. The aim of this study was to examine whether exposure to antiepileptic drugs during pregnancy has an effect on early child development.

METHODS:
From mid-1999 through December 2008, children of mothers recruited at 13-17 weeks of pregnancy were studied in the ongoing prospective Norwegian Mother and Child Cohort Study. Information on birth outcomes were obtained from the Medical Birth Registry (108,264 children), and mothers reported on their child’s motor development, language, social skills, and autistic traits using items from standardized screening tools at 18 months (61,351 children) and 36 months (44,147 children) of age. The relative risk of adverse outcomes in children according to maternal or paternal epilepsy with and without prenatal exposure to antiepileptic drugs was estimated as odds ratios (ORs), using logistic regression with adjustment for maternal age, parity, education, smoking, depression/anxiety, folate supplementation, and child congenital malformation or low birth weight.

KEY FINDINGS:
A total of 333 children were exposed to antiepileptic drugs in utero. At 18 months, the exposed children had increased risk of abnormal scores for gross motor skills (7.1% vs. 2.9%; OR 2.0, 95% confidence interval [CI] 1.1-3.7) and autistic traits (3.5% vs. 0.9%; OR 2.7, CI 1.1-6.7) compared to children of parents without epilepsy. At 36 months, the exposed children had increased risk of abnormal score for gross motor skills (7.5% vs. 3.3%; OR 2.2, CI 1.1-4.2), sentence skills (11.2% vs. 4.8%; OR 2.1, CI 1.2-3.6), and autistic traits (6.0% vs. 1.5%; OR 3.4, CI 1.6-7.0). The drug-exposed children also had increased risk of congenital malformations (6.1% vs. 2.9%; OR 2.1, CI 1.4-3.4), but exclusion of congenital malformations did not affect the risk of adverse development. Children born to women with epilepsy who did not use antiepileptic drugs had no increased risks. Children of fathers with epilepsy generally scored within the normal range.

SIGNIFICANCE:
Exposure to antiepileptic drugs during pregnancy is associated with adverse development at 18 and 36 months of age, measured as low scores within key developmental domains rated by mothers. Exposures to valproate, lamotrigine, carbamazepine, or multiple antiepileptic drugs were associated with adverse outcome within different developmental domains.

Sources: Exposure to antiepileptic drugs in utero and child development: a prospective population-based study
NCBI, July 2013

For Related Posts, see our Tags:
AEDsEpilepsyNCBIPregnancy
DrugsDépakineEpilimValproate

Epilim Sodium Valproate in Pregnancy

BBC1 Interview with Emma Friedmann of FACSaware

BBC1 East Midlands talks to Emma Friedmann, FACSaware, about the Flawed Warning System and the MHRA Protest

  • Video by jocozens1, Published on 31 Jul 2013
  • FACSaware aims to raising global awareness of Fetal Anti Convulsant Syndromes and other Teratogen related syndromes. The Fetal AntiConvulsant Trust (F.A.C.T.) was set up in 2011 to campaign for responsibility from the government and drug company.

Related posts:

Watch The Wales Report Dangers of Epilim in Pregnancy

Results clearly show that Valproate acts on the fetus btain

The Dangers of Sodium Valproate in Pregnancy… Film is by Wales&Co for BBC Wales

  • Video by jocozens1, Published on 11 Aug 2013
  • FACSaware aims to raising global awareness of Fetal Anti Convulsant Syndromes and other Teratogen related syndromes. The Fetal AntiConvulsant Trust (F.A.C.T.) was set up in 2011 to campaign for responsibility from the government and drug company.

Related posts: