Epilim (Sodium Valproate) Birth Defects
Coleman Legal LLP
Apr 26, 2017

Epilim (Sodium Valproate) Birth Defects

Birth Defects for any reason can be devastating for families, and may result in full time care for the affected infant, and their families.

Sodium Valproate is a drug given to pregnant women who suffer from bipolar disorder between 1967 AND 2016 –  more commonly known as Epilim/Depakine/Depakote/Depamide – has resulted in severe birth defects in up to 4,100 children in France according to the French Health Authorities  after their mothers took the epilepsy drug sodium valproate.

Dr Mahmoud Zureik, the scientific director of France’s ANSM, found that the risk of major birth defects was globally four times higher in children born to a woman treated with Valproate for epilepsy, when compared to women who did not receive the drug:

“The study confirms the very important teratogenicity of Valproate. Around 3,000 major malformations are particularly high.”

Epilim use in Ireland

Epilim has been licensed for use in Ireland since 1983 to treat epilepsy and bipolar disorder.  The FACS Forum – which includes the Disability Federation of Ireland, Epilepsy Ireland, the Organisation for Anti-Convulsant Syndrome Ireland, the Migraine Association of Ireland, Shine, the Genetic and Rare Disorders Organisation, and the Medical Research Charities Group – estimates that 400 infants may have been born here with foetal valproate syndrome as a result.

It is also believed to have been taken by thousands of pregnant women in the UK.

What is Foetal Valprote Syndrome?

  • Foetal Valproate Syndrome is a rare congenital disorder caused by exposure of the foetus to valproic acid (dalpro, depakene, depakote, depakote sprinkle, divalproex, epival, myproic acid) during the first three months of pregnancy.
  • Valproic acid is an anticonvulsant drug used to control certain types of seizures in the treatment of epilepsy. A small percentage of pregnant women who take this medication can have a child with Foetal Valproate Syndrome.
  • Symptoms of this disorder may include spina bifida, distinctive facial features, and other musculoskeletal abnormalities.
  • Affected infants are at higher risk of developmental problems such a decreased cognitive function, attention deficit disorder, learning difficulties and autism spectrum disorders.

Symptoms of Foetal Valprote Syndrome

Infants with Foetal Valproate Syndrome may be born with spina bifida. Spina bifida is the incomplete closure of bony spine. It occurs when the tube of tissue that lies along the center of the early embryo (neural tube) does not completely fuse during fetal growth. Part of the contents of the spinal canal may protrude through this opening (bifida cystica). Depending on the severity of the opening, a variety of neurological and physical symptoms may occur.

Distinctive facial features are characteristic of Foetal Valproate Syndrome. Affected infants may have a vertical fold of skin on either side of the nose that forms a groove under the eye (epicanthal folds); a small, upturned nose with a flat bridge; a small mouth (microstomia); a long, thin, upper lip; a downturned mouth; and/or minor abnormalities of the ears.

Other abnormalities that may be found in a few affected individuals include:

  • underdeveloped nails of the fingers and toes;
  • dislocation of the hip; long, thin fingers and toes (arachnodactyly);
  • overlapping fingers and toes; separation of the rectus muscle of the abdominal wall (diastasis recti);
  • absence of the first rib; a condition in which the urinary opening is on the underside of the penis (hypospadias);
  • abnormalities of the heart; softening of the windpipe (tracheomalacia);
  • and/or a club foot.

Growth deficiency and an unusually small head (microcephaly) may also occur when valproic acid is taken in combination with other anticonvulsant drugs during pregnancy.

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