The South African Health Products Regulatory Authority (SAHPRA), in collaboration with manufacturers of sodium valproate have issued a statement to inform the community about the new implemented measures aimed at reducing the risk of sodium valproate use in pregnancy.
According to the statement, valproate-containing medicines are anticonvulsant medicines used to treat epilepsy and also used as a mood stabiliser in the treatment of bipolar mood disorder. Valproate is associated with a very high risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.
An estimated 10 % of babies (one in ten) exposed to valproate during pregnancy are likely to develop a serious physical birth defect such as: spina bifida, facial and skull malformations such as cleft lip, heart, kidney and limb defects. According to the statement, 30-40 % of children whose mothers took valproate while pregnant could develop long term developmental problems such as: walking or talking late, learning disabilities and lower intelligence compared to other children of the same age, poor speech and language skills, memory problems and increased likelihood of having autism and autistic spectrum disorder as well as a higher risk to develop symptoms of attention deficit hyperactivity disorder (ADHD).
SAHPRA and valproate manufacturers have implemented new measures which aim to ensure that girls and women of child-bearing potential are not started on valproate treatment unless no other effective treatment is available, and girls and women already on valproate treatment are made well aware of the risks of using valproate during pregnancy and the need to take adequate measures to avoid falling pregnant while on valproate.
Manufacturers of sodium valproate include: Epilim, Epilizine, Navalpro, Eprolep, Adco Sodium Valproate, Valeptic, Sandoz Sodium Valproate, Cerepiv and Convulex. Healthcare professionals and consumers in South Africa are urged to report any adverse reactions to the National Adverse
Drug Event Monitoring Centre at
021 447 1618.