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New safety measures around sodium valproate endorsed by European medicines regulatory body

11 Apr 2018

New measures to avoid valproate exposure of babies during pregnancy have been backed by medicines regulatory body CMDh.

The new measures were recommended by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC).

They say that valproate medicines should be banned from use in epilepsy during pregnancy, unless there is no other effective treatment. They also say the medicine should be banned from use to treat bipolar disorder or migraines in pregnant women.

In addition, the measures say a new pregnancy prevention programme should be used. This would make women fully aware of the risks of becoming pregnant while taking sodium valproate. The new measures say women of childbearing age should not be prescribed valproate unless the conditions of this new programme are met.

A clear warning should also appear on the packaging of these medicines.

The CMDh represents member states of the EU, as well as Iceland, Liechtenstein and Norway. Its position on the issue will be sent to the European Commission, who will make the final decision.

The final decision will be legally binding across the EU and is expected in the next few months.

The new measures follow the recent safety review and public hearing on the use of valproate medicines during pregnancy. While safety measures have been put in place before, there were concerns that they did not go far enough.

Sodium valproate is an epilepsy medicine which can be very effective in treating seizures in some people. For some people, it may be the only medicine that works.

However, there is a risk of birth defects and developmental problems in babies born to mothers taking the medicine during pregnancy. Other epilepsy medicines carry a small risk of these complications, but the risks with sodium valproate are higher.

Epilepsy Action advises that women taking epilepsy medicines continue to do so as prescribed, unless advised otherwise by their doctor.

Women should speak to their doctor if they have concerns about their medicine. Stopping epilepsy medicine could result in breakthrough or worsened seizures, which could harm the mother and baby.

 

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