Women to be better informed of the risks of valproate use during pregnancy
The European Medicines Agency (EMA)’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb.
” Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated. Women for whom valproate is the only option after trying other treatments, should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.” … continue reading EMA press release, 10/10/2014.
The review of valproate medicines has been requested by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) following the publication of new studies suggesting that in some children problems in development, which can include autism, may be long-lasting. The MHRA also noted that there was a need to update the product information of these medicines to bring them in line with current evidence.
The European Medicines Agency will now review the available data on the benefits and risks of valproate and related substances and issue an opinion on the use of these medicines in pregnant women. ”