Sodium Valproate Safety Update

This was following INFACTs meeting with the MHRA in August last year… A safety update was officially released

 

Drug SafetyUpdate

Volume 7, Issue 4 November 2013

Latest advice for medicines users

Sodium valproate: special reminder on risk of neurodevelopmental delay in children following maternal use—not for use in pregnancy unless there is no effective alternative

Article date: November 2013

Summary
There is new evidence on neurodevelopmental delay in children following maternal use of sodium valproate. A European review is underway to evaluate all currently available evidence on the association between fetal valproate exposure and neurodevelopmental delay or autism spectrum disorder

Healthcare professionals are reminded that sodium valproate should not be used during pregnancy and in women of childbearing potential unless clearly necessary. Women of childbearing potential should not start treatment with sodium valproate without specialist neurological or psychiatric advice as appropriate depending on the indication. Adequate counselling should be made available to all women of childbearing potential to weigh the risk of teratogenic and neurodevelopmental effects against the benefits of treatment

Sodium valproate (brand name Epilim) has been authorised since 1973 for the treatment of epilepsy. Depakote is the brand of sodium valproate authorised for the treatment of the manic phase of bipolar disorder.

Risks during pregnancy

It is well established that women who take antiepileptics during pregnancy have a higher risk of having a child with a birth defect than do women in the general population—this risk is estimated to be 2–3 times higher. This risk is further increased if a woman takes more than one antiepileptic medicine during pregnancy.

The use of sodium valproate is associated with a greater risk of some types of these malformations (in particular neural tube defects) than with some other antiepileptic drugs. This risk is clearly reflected in the product information provided for patients and prescribers.

In recent years, results of further studies have emerged that indicate a risk of long term neurodevelopmental effects after in uteroexposure to sodium valproate. These studies have highlighted that in some children the effects appear to persist and manifest as a range of neurodevelopmental abnormalities and autism spectrum disorders. These emerging data also suggest that these risks may be independent of maternal confounders.[1] [2] [3] [4]

The most recent publications on an association between fetal valproate exposure and neurodevelopmental delay or autism spectrum disorder have prompted a re-evaluation of the balance of benefits and risks of this medicine. The review is now underway in Europe, and further updates will be issued in due course. In the meantime, healthcare professionals are reminded of the following advice:

Advice for healthcare professionals:

  • Sodium valproate should not be used during pregnancy and in women of childbearing potential unless clearly necessary
  • Women of childbearing potential should not start treatment with sodium valproate without specialist neurological or psychiatric advice as appropriate depending on the indication
  • Adequate counselling should be made available to all women of childbearing potential to weigh the risk of teratogenic and neurodevelopmental effects against the benefits of treatment
  • In the bipolar disorders indication, cessation of sodium valproate treatment should be considered if there is an effective alternative
  • If sodium valproate is to be used during pregnancy, the lowest effective dose is recommended divided over the day or controlled-release tablets to avoid rapid peaks in plasma level
  • Folate supplementation should be started before pregnancy as appropriate
  • Specialist prenatal monitoring should be instigated to detect possible occurrence of neural tube defects or other malformations when valproate has been used

Further information

Product information for Epilim and Depakote

Article citation: Drug Safety Update volume 7 issue 4, November 2013: A2.

References

  • 1 Meador KJ, et al. Lancet Neurol 2013; 12: 244–52.
  • 2 Bromley R, et al. J Neural Neurosurgery Psychiatry 2013; 0: 1–7.
  • 3 Christensen J, et al. JAMA 2013; 309: 1696–703.
  • 4 Veiby G, et al. Epilepsia 2013; 54: 1462–72
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