Tag: EU Medicines Agency

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

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.

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  • Published on 12 Oct 2014 by APESAC channel. Website.
  • ” 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.
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Review of Valproate and Related Substances and their Use in Pregnant Women – EU Medicines Agency

Women to be better informed of risks of valproate use in pregnancy and need for contraception

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Latest news from the European Medicines Agency, the European Union agency responsible for the evaluation and supervision of medicines.

” The European Medicines Agency has started a review of valproate and related substances and their use in pregnant women.

Valproate medicines are used for treating epilepsy and bipolar disorder. It has been known for some time that using anti-epileptic medicines in pregnant women increases the risk of birth defects in their children and that valproate medicines may be associated with a higher risk of certain birth defects than other anti-epileptic medicines. It has also been known that development may be delayed in children born to women who were treated with valproate medicines during pregnancy. The product information for valproate medicines in the EU contains information on their use during pregnancy.

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. ”

Sources European Union Medicines Agency Press Release – PDF