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Stricter Controls on Medicine Linked to Birth Defects

Strict Controls Made Stricter on Medicine Linked to Birth Defects

Date: 4 March 2019

Greater restrictions around the use of sodium valproate (Epilim) to treat bipolar disorder in girls and women have been put in place. This is because of a clearer picture emerging of the risks of harm and the continuing exposure of unborn babies in pregnancy.

Following further consideration by an expert committee Medsafe is advising healthcare professionals of the changes to the bipolar indication and reminding about the risks in pregnancy for all girls and women taking sodium valproate.

Medsafe Group Manager Chris James says healthcare professionals and consumers should be aware that sodium valproate should now only be used for treating bipolar disorder in girls and women when all other treatments are found to be ineffective or not tolerated.

And where it is used in girls or women able to have children, they must use effective contraception and the medicine can only be started by a specialist. Regular review from a specialist should also occur. Sodium valproate must not be used during pregnancy for the treatment of bipolar disorder.

Sodium valproate is also used in the treatment of epilepsy and the same concerns exist for girls and women who are able to have children. There have been restrictions on its use during pregnancy since 2005. Sodium valproate must not be used during pregnancy for the treatment of epilepsy unless there is no suitable alternative.

The risks to the unborn baby are higher with sodium valproate than with other medicines for epilepsy or bipolar disorder.

The risks are present even with low doses of sodium valproate and increase with higher doses.

Further information about the risks and benefits of antiepileptic medicine for females (booklets for health professionals and their female patients) are available at


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