Other safety alerts

European Union: New review of valproate use in pregnancy and women of childbearing age – EMA to consider if risks of these medicines require further restrictions of use

The European Medicines Agency (EMA) has started a review looking at the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. These medicines are approved nationally in the EU to treat epilepsy, bipolar disorder and in some countries, migraine, and have been previously reviewed by the Agency.

An EMA review in 2014 resulted in measures to strengthen the warnings and restrictions on the use of valproate medicines in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb. Although sometimes there may be no alternative to using valproate, these measures aimed to ensure that patients are aware of the risks of doing so, and that they take valproate only when clearly necessary. The 2014 review also recommended studies at EU level to measure how effective the proposed measures were.

Some EU member states have since carried out additional assessments of the impact of the measures at national level and concerns have been raised about how effective the measures have been in increasing awareness and reducing valproate use appropriately in its various indications. The French medicines regulator, ANSM, therefore asked EMA to review the effectiveness of the measures and to consider whether further EU-wide action should be recommended to minimise the risks in women who are pregnant or of childbearing age.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will examine the available evidence and will consult with relevant stakeholder groups. This will include holding a public hearing about their concerns. While the review is ongoing, patients prescribed valproate who have any concerns about their medication should discuss them with their healthcare professionals.

Please refer to the following website in EMA for details: http://www.ema.europa.eu/../human_referral_prac_000066.jsp&mid=WC0b01ac05805c516f

In Hong Kong, there are 12 registered pharmaceutical products containing valproic acid or valproate, and are prescription only medicines. In December 2014, the Registration Committee of the Pharmacy and Poisons Board discussed the matter in response to EMA’s review in 2014. The Registration Committee decided that sales pack and/or package insert of the products containing valproic acid or valproate should be updated to include the relevant warnings and precautions. So far, the Department of Health (DH) has received six cases of adverse drug reactions in connection with valproic acid or valproate, but none of them was related to malformations or developmental problems in babies who are exposed to valproate in the womb. It is noted that EMA will conduct a review on the effectiveness of the measures and make further recommendation to minimise the risks in women who are pregnant or of childbearing age. DH will remain vigilant on the conclusion of the review and safety update on the drug by other overseas drug regulatory authorities.

Ends/ Monday, March 13, 2017
Issued at HKT 15:00

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