Sodium valproate

Sodium valproate (INN) or valproate sodium (USAN) is the sodium salt of valproic acid and is an anticonvulsant used in the treatment of epilepsy and bipolar disorder, as well as other psychiatric conditions requiring the administration of a mood stabilizer. The intravenous formulations are used when oral administration is not possible.

Formulations
Trade names are in bold, followed by the manufacturer.

U.S.

 * Intravenous injection – Depacon by Abbott Laboratories.
 * Syrup – Depakene by Abbott Laboratories. (Note Depakene capsules are valproic acid).

Australia

 * Epilim Crushable Tablets Sanofi-Aventis
 * Epilim Sugar Free Liquid   Sanofi-Aventis
 * Epilim Syrup   Sanofi-Aventis
 * Epilim Tablets   Sanofi-Aventis
 * Sodium Valproate Sandoz Tablets   Sanofi-Aventis
 * Valpro Tablets   Alphapharm
 * Valproate Winthrop Tablets   Sanofi-Aventis

UK

 * Tablets – Orlept by Wockhardt and Epilim by Sanofi-Aventis.
 * Oral solution – Orlept Sugar Free by Wockhardt and Epilim by Sanofi-Aventis.
 * Syrup – Epilim by Sanofi-Aventis.
 * Intravenous injection – Epilim Intravenous by Sanofi-Aventis.
 * Extended release tablets – Epilim Chrono by Sanofi-Aventis. A combination of sodium valproate and valproic acid in a 2.3:1 ratio.
 * Enteric-coated tablets – Epilim EC200 by Sanofi-synthélabo. A 200 mg sodium valproate enteric-coated tablet.

UK only

 * Capsules – Episenta prolonged release by Beacon.
 * Sachets – Episenta prolonged release by Beacon.
 * Intravenous solution for injection – Episenta solution for injection by Beacon.

Germany, Switzerland, Norway

 * Tablets – Orfiril by Desitin Pharmaceuticals
 * Intravenous injection – Orfiril IV by Desitin Pharmaceuticals

South Africa

 * Syrup – Convulex by Byk Madaus
 * Tablets – Epilim by sanofi~synthelabo

Canada

 * Intravenous injection – Epival or Epiject by Abbott Laboratories.
 * Syrup – Depakene by Abbott Laboratories. Generic formulations include Apo-Valproic and ratio-Valproic.

Japan

 * Tablets – Depakene by Kyowa Hakko Kogyo.
 * Extended release tablets – Depakene-R by Kyowa Hakko Kogyo and Selenica-R by Kowa.
 * Syrup – Depakene by Kyowa Hakko Kogyo.

Europe
In much of Europe, Depakine and Depakine Chrono (tablets) are equivalent to Epilim and Epilim Chrono above.

Safety in pregnancy
All antiepilepic medications have been shown to be associated with higher risks of fetal abnormalities (mostly for spina bifida) since at least 1983 with the risks being related to the strength of medication used and use of more than one drug. Valproate has also been recognised as sometimes causing a specific facial changes ("facial phenotype") termed "fetal valproate syndrome". Sodium valproate has been associated with the rare condition Paroxysmal tonic upgaze of childhood from childhood exposure(Epileptic Disord. 2007 Sep;9(3):332-6) and also fetal exposure (This condition resolved after discontinuing valproate therapy. Ouvrier-Billson syndrome (J Child Neurol. 1988 Jul;3(3):177-80) is the name used for this condition, to honor the discoverer.

Whilst developmental delay is usually associated with altered physical characterists (dysmorphic features), this may occur on its own.

A 2005 study found rates of autism among children exposed to sodium valproate before birth in the cohort studied were 8.9%. The normal incidence for autism in the general population is estimated at less than one percent. It has been suggested that Valproate may best be avoided in women with localisation epilepsy, where there are more effective and less risky alternatives such as carbamazepine.

A class action is currently underway in the United Kingdom regarding the claim that the drug used in pregnancy caused a range of problems in children, including autism, learning and social difficulties, ADHD, spinal stenosis, facial abnormalities, vision defects, dyslexia, dyspraxia, delayed speech and motor development.

A 2008 study also suggested a correlation between higher rates of autism in children whose mothers were treated for seizure disorders during pregnancy using sodium valproate (less than 1% for children who didn't receive the drug in vitro vs. 6.3% for children who did). However, only 632 children were followed in this study, prompting criticism that this study was too small to rely on to say whether there was a definitive correlation between the use of sodium valproate in pregnant mothers and higher autism rates in their children, or whether other anti-seizure medications used during pregnancy don't cause this effect.