Sodium Valproate

Used to treat Epilepsy and Bi-Polar Disorder and off-label : migraines 

Valproate is classed as an anti-epileptic drug which has been marketed under the names Sodium Valproate, Epilim Depakote, Depakote ER, Depakene, Depakene Crono (extended release in Spain), Orfinil Depacon, Depakine, Valparin, Stavzor Convulex, Valporal and Valprosid

Background

Valproic acid was first synthesized in 1881 by Beverly S. Burton as a similar compound to Valeric acid, found naturally in the herb valerian.

For many decades, its only use was in laboratories because it was believed to be not used by the body. In 1962, the French researcher Pierre Eymard discovered the anticonvulsant properties of valproic acid while using it as a vehicle for a number of other compounds that were being screened for anti-seizure activity. He found it prevented pentylenetetrazol-induced convulsions in laboratory rats. It was approved as an antiepileptic drug in 1967 in France and has become the most widely prescribed antiepileptic drug worldwide. Valproic acid has also been used for bi-polar disorder, off label, for migraine prophylaxis. 

 

Sodium Valproate achieved a black triangle status in January 2015 and added to the black box scheme as a teratogen by the FDA (US food and drug administration) in May 2014.

https://www.gov.uk/drug-safety-update/the-black-triangle-scheme-or 

 

The MHRA (Medicines and Health Products Regulatory Agency) has changed its regulatory position on medicines containing Sodium Valproate.  The MHRA now advises that if a females of child bearing potential: any girl or woman that is able to have a baby in her future will have to enrol in the Pregnancy Prevention Programme, (PPP) if she chooses to take sodium valproate.

 

For more information:

 

 https://www.youtube.com/watch?v=VuBq2M1Me04

 

https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-pregnancy-prevention-programme-materials-online

 

 

1 in 10 babies, to a woman taking sodium valproate, will have a physical birth defect, in 3-4 out of 10 babies will have a neuro-developmental effect, including severe disabilities.  

 

In a 15 year period it has been estimated that 20,000 babies have a ‘Fetal valproate Spectrum Disorder. https://rarediseases.org/rare-diseases/fetal-valproate-syndrome/ This is caused by the teratogenic effects of sodium valproate: This means that the medicine, has crossed the placenta and affected the developing foetus.

 

In February 2018, the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices. The announcement in the House of Commons follows patient-led campaigns on the use of the hormone pregnancy test Primodos, anti-epileptic drug sodium valproate and surgical mesh. 

The Independent Medicines and Medical Devices Safety Review (also often referred to as the Cumberledge Review) has finished taking evidence, and is now working with patient groups to develop a timeline.

 

 http://immdsreview.org.uk/index.html

More information on Sodium Valproate: UKTIS

Patient Stories