NEWS RELEASE
FOR IMMEDIATE RELEASE 21 NOVEMBER 2014
TIGHTER CONTROLS FOR SODIUM VALPROATE MEDICATION USED IN EPILEPSY AND BIPOLAR DISORDER RECOMMENDED FOR PREGNANT WOMEN
A branch of a leading European medicines agency, the EMA (or European Medicines Agency) – whose main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.) – has recommended tighter controls on the use of Sodium Valproate for pregnant women and girls.
The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) issued a statement on the 10th of October 2014 to suggest that restrictions of Sodium Valproate, (which is used to treat epilepsy and bipolar disorder, migraines, anxiety, depression, and neuropathic pain) should be strengthened.
It has been known for many years that malformations in children exposed to Valproate in the womb) the EMA gives this figure as 11% for Valproate babies as compared to 2-3% of the general population.
The move has come because of new concerns, as recent evidence proves that there is a risk of developmental delay (evidenced as between 30-40% of children). Data also shows that children exposed to Valproate in the womb are at increased risk of Autistic Spectrum Disorder (around three times higher than in the general population) and childhood Autism (five times higher than in the general population). There is some more limited data to suggest that children exposed to Valproate in the womb may also be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
Doctors in the EU are now advised not to prescribe valproate for epilepsy or bipolar disorder in pregnant women, and in women and girls of child bearing potential unless other treatments are ineffective or not tolerated. Those for whom valproate is the only option after trying other treatments should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions. The UK has just licensed Valproate to be also prescribed for migraine, and where this is the case during pregnancy, alternative options to treatment should be quickly investigated. The guidance recommends that doctors should take measures to exclude pregnancy before endorsing a plan of treatment of using Valproate for migraine The EMA recommend the importance of doctors providing patients with up-to-date and effective information to help them make informed choices about the risks and their subsequent decisions for childbirth. The Committee concluded that women and healthcare professionals need to be better informed about the risks of Valproate exposure in the womb and of the need for effective contraception.
Several support groups in the UK, including OACS (Organisation for Anti-Convulsant Syndrome), a patient-led registered charity, for families with children with Fetal Anti-Convulsant Syndrome have helped to bring about this change. By calling upon parliamentarians in the UK, the groups have managed to raise concerns about the use of Sodium Valproate during pregnancy to provide information to future mums-to-be taking the drug so that they can make informed choices.
Jo Cozens, the interim chairperson of OACS commented: “At last the group feels as if we are really getting somewhere; I know I speak for all effected families the country over. We would like to give other women, taking sodium valproate, a future with the best possible outcomes. The OACS charity has been working since 1999 to support these families.
The recommendations on the use of valproate in women and girls will be implemented by EU Member States according to an agreed timetable.
With a special thanks to the Antiepileptic Drugs in Pregnancy (AED-iP): Maternal and Child Health Advisory Group for their help and support, we cannot thank the team enough for their efforts.
Let’s hope that judge led public enquiry will now take place, with these results vindicating what our families have known for years. We need to find all of the Forgotten Children of Sodium Valproate, estimated 20,000 – 50,000 affected, since the launch of the drug. These forgotten children are costing taxpayers in excess of £30 – £60 Billion in Health Care, Social Care, Education and Housing”
The review of valproate was conducted by the EMA’s Pharmacovigilance and Risks Assessment Committee (PRAC), following which the CMDh endorsed the PRAC’s recommendations.
Patients are advised to consult their doctor if they are planning to become, or think they may be pregnant and are taking Valproate.
ENDS
Media Enquiries: Please contact email: oacsmedia@gmail.com Tel: 0208 3869271
NOTES FOR EDITORS:
- More about OACS can be found at the following website: http://www.oacscharity.org/#!about1/ch9m
- Jo Cozens has been blogging about FACS and her website can be found at the following website: https://jocuz1971.wordpress.com/
- For anyone with concerns about FACS OACS, has a full advocacy support tailored to individual cases, this can be found at the following link: oacscharity.org
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