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Valproate: UK regulator looks into possible transgenerational effects

BMJ 2022; 377 doi: (Published 22 June 2022) Cite this as: BMJ 2022;377:o1531
  1. Jacqui Wise
  1. Kent

The UK’s medicines regulator is examining animal data that show that the epilepsy drug sodium valproate could trigger genetic changes that are passed on to future generations.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said that as part of its ongoing review of the safety of sodium valproate it has sought independent advice from the Commission on Human Medicines about animal data that show changes to the testes in juvenile male animals and transgenerational effects in mice.

In April new figures showed that valproate was still being prescribed to women of childbearing age.12

Valproate is highly teratogenic, and evidence supports a rate of congenital malformations of 10% in infants whose mothers took valproate during pregnancy and neurodevelopmental disorders in 30-40% of children in this group.

Data from NHS Digital show that 206 women aged under 54 were started on …

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