Women ‘need clear warnings’ on valproate pregnancy risk
Women of childbearing age need to be better informed of the risks related to the use of sodium valproate during pregnancy.
This is according to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), which issued a statement on Wednesday (January 21st) calling for clearer warnings about the side-effects of the common antiepileptic drug.
Valproate, which is prescribed to around 35,000 women with epilepsy and bipolar disorder per year, is known to cause a wide range of developmental disorders when exposed to babies in the womb.
Nonetheless, approximately 375 patients annually become pregnant while taking the drug, with 40 per cent of their offspring showing problems like delayed walking and talking, according to a recent European review.
For its part, the MHRA is distributing information booklets to patients and professionals, as well as updating the guidance contained in the literature inside valproate packaging.
“If valproate is the only option, women of childbearing age should be given effective contraception,” commented Dr June Raine of the MHRA’s vigilance and risk management division.
“Women taking valproate must have regular reviews of their treatment.”
Posted by Bob Jones