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September 29, 2017updated 13 Oct 2017 12:02pm

Over two thirds of women unaware of sodium valproate safety risks

Around 30–40% of babies born to mothers taking sodium valproate have neurological or developmental difficulties.

By GlobalData Healthcare

Around 30–40% of babies born to mothers taking sodium valproate have neurological or developmental difficulties.

The drug is used to treat conditions such as epilepsy, migraine and bi-polar disorder, and is listed on the WHO list of essential medicines for healthcare systems.

However, it has many side effects, and can have severe effects on fetal development during pregnancy.

The government produced new guidelines for patients taking sodium valproate in 2016.

The document, part of a toolkit on the risks of the drug in female patients, outlines the potential consequences on fetal development, which include high or increased risks of spina bifida, autism, low IQ, craniofacial abnormalities, deformed or missing limbs, and malformations of the heart, kidney, urinary tract and sexual organs.

An unrecognized danger

A survey of UK women taking valproate found that 68% said they are unaware of this new document and the risks to pregnancy, despite the boxed warning on all valproate products .

This frightening statistic demonstrates a clear need for GPs to better convey the serious risks of valproate use in those who may become pregnant.

Ineffective warnings about the safety of valproate are not only a problem for the UK; over 4,000 babies in France have been born with birth defects to mothers taking valproate, and many more were born with developmental issues such as low IQ.

More action needed

Despite the fact that the consequences of valproate use in pregnancy have been known for decades, it only stopped being advised for pregnant women in France in 2015, and may still be used in patients resistant to other medicines.

Likewise, the boxed warning for the use of valproate in pregnancy was only added in 2016.

Steps are now being taken in the UK to ensure that women are aware of the potential risks for valproate – including mandatory face-to-face consultations for all patients who are expected to take the drug for more than 12 months.

This may not go far enough, however, and legislators may need to consider mandatory explanations of boxed warnings by GPs for all drugs for any duration of use, and speeding up the process of boxed warnings being issued for drugs with serious side effects.

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