EU Body Endorses Restrictions on Valproate in Pregnancy

Pauline Anderson

March 27, 2018

The CMDh, a body representing European Union (EU) member states, has endorsed new measures to limit prenatal exposure to valproate, according the European Medicines Agency (EMA).

Prenatal exposure to valproate is linked to a high risk for malformations and developmental problems in offspring.

The new measures include a ban on the use of medicines containing valproate for migraine or bipolar disorder during pregnancy and a ban on treating epilepsy during pregnancy with the drug unless no other effective treatment is available. 

Another recommendation from the CMDh (which stands for Coordination Group for Mutual Recognition and Decentralised Procedures - Human) is that women of childbearing age not use these medicines unless conditions of a new pregnancy prevention program are met. These conditions include the following:

  • An assessment is done for each patient's potential for becoming pregnant;

  • Pregnancy tests are carried out before and during treatment as needed;

  • Counseling is offered about the risks of valproate and the need for effective contraception throughout treatment; and

  • A review of ongoing treatment is carried out by a specialist at least annually.

Valproate is contraindicated in pregnancy, and an alternative treatment should be determined for women planning pregnancy. However, the small number of women with epilepsy for whom there is no suitable alternative should be appropriately supported and counseled, said an EMA press release.

Women who have been prescribed valproate should not stop taking it without consulting their doctor because doing so could result in harm to themselves or to an unborn child.

The new measures also dictate that boxed text, with other possible visual elements, such as a warning symbol, be placed on the packaging of these medications, with accompanying warnings each time the medication is dispensed.

The CMDh, which  represents EU member states, as well as Iceland, Liechtenstein, and Norway, agreed with EMA's Pharmacovigilance Risk Assessment Committee, which carried out a review and recommended these new measures.

The measures strengthen existing restrictions on valproate use and requirements to inform women of the risk. 

"Although steps had been taken previously to better inform women about these risks and discourage use of valproate in girls and women unless there was no alternative, the evidence shows that this information is still not getting to patients," said the press release.

According to the new recommendations, companies marketing these medicines will be required to perform additional studies on the nature and extent of the risks and to monitor valproate use and the long-term effects from affected pregnancies.

In addition, such companies will need to have a risk management plan that details the measures taken to ensure that a medicine is used as safely as possible.

The CMDh position will now be sent to the European Commission, which will make a final legally binding decision. 

Healthcare professionals will receive further information as the recommendations are implemented.

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