42 years later and an estimated 20,000 babies affected by the Prescription Drug Sodium Valroate (Epilim) manufacturers Sanofi have FINALLY admitted that their drug DOES harm babies when taken during pregnancy. When 1st marketed back in 1972, it was originally only prescribed for Grand Mal and Petite Mal Epilepsy , as the years have passed it in now also prescribed for
- Bipolar disorder
- Pain relief
Following the recommendations of the EMA, Sanofi has sent a letter to healthcare professionals to warn of the dangers of Sodium Valproate during pregnancy.
- Children exposed to valproate in utero have an increased risk of developmental disorders (30 to 40% of births) and / or birth defects (in approximately 10% of cases)
- Valproate should not be prescribed to female children, adolescents, women of childbearing age, women who may be pregnant unless other treatments are ineffective or not tolerated.
- Treatment with valproate should be initiated and supervised by a physician experienced in the management of epilepsy and bipolar disorder.
- We must carefully measure the benefit / risk of valproate treatment before prescribing valproate for the first time, when renewing, when a girl reaches puberty and when a woman wishes to become pregnant or become pregnant.
You must ensure that all patients are informed and understand:
- The risks associated with valproate during pregnancy;
- They must use effective contraception;
- The need for a regular review of the treatment;
- The need to quickly check if planning pregnancy or become pregnant.
Any child that has been exposed to Sodium Valproate may suffer symptoms such as:
- Premature Birth
- Small fingernail
- Spina Bifida / Cerebral Palsy
- Limb defects
- Joint Laxity
- Characteristical facial features
- Delay in reaching milestones
- Gross and fine motor skills
- Autistic Spectrum Disorders
- Speech and Language Delay
- Attention and memory difficulty
- Vision problems
- Inguinal Hernia
and officially go on to obtain a medical diagnosis of FACS (Fetal Anti Convulsant Syndrome) What is FACS? http://facsa.org.uk/vital-knowledge/
In August 2013 we (INFACT) had our first meeting with the Pharmacovigilence Director June Raines following our Panorama programme in July 2013, where we asked for an investigation into the reasons why Valproate had been allowed to harm so many in pregnancy.
Since the drug came onto the market in 1973, it has touched 20,000 with 40% of those suffering neurodevelopmental disorders (8000). Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases)
These figures were agreed at that meeting as both INFACT & MHRA had used the same research papers in calculation.
After being turned down for a public enquiry, We were so pleased that our innitiation of an investigation into Valproate in pregnancy was accepted. In October 2013 a European Review began through the European Medicines Agency (EMA) and some of their conclusions were released on the 10th October 2014 (see link) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate/human_referral_000187.jsp
Approximately 500 babies are affected by Sodium Valproate each year and with it being prescribed for so many illness, it is appalling that so many children have been affected and disabled due to this medicine. What’s even more appalling is that UK Government KNEW about the effects of the medicine and allowed it to be prescribed for all of the above.
In a meeting we had recently with Norman Lamb, Minister for Care and Support he stated :
“What frustrates me is that know we all now that prescribing this to women of childbearing age, unless totally necessary is a total disaster. It is a very stupid thing to do and yet we also know that not many GPS know about this”
“Going back to the issue of those that already have this, and you have it in many cases because the message hasn’t got across, and there’s been a failure of the system really, there is a responsibility to make sure that we think through and support those people through good care given for what happened to them.”