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Issues surrounding sodium valproate discussed at House of Lords debate

11 Mar 2019

The UK’s House of Lords held a debate on the safety of medicines and medical devices on 28 February, discussing issues around sodium valproate.

Sodium valproate is an epilepsy medicine. Its use during pregnancy has been linked with an increased risk of developmental problems and birth defects in babies. However, it can be a very effective epilepsy medicine, and in some women, it can be the only medicine that works.

The debate follows the government’s Independent Medicines and Medical Devices review into three ‘public health scandals’, which was launched on 22 February 2018. Baroness Cumberlege is chairing the review, which is looking into three separate scandals surrounding medicines and medical devices. These are sodium valproate, the pregnancy test drug Primodos, and the vaginal mesh implant. The findings of the review are expected to be reported later this year, alongside recommendations for improvements. Several organisations and patient groups, including Epilepsy Action, have submitted evidence for the review.

The debate was secured and opened by Lord O’Shaughnessey. He quoted figures from the Independent Fetal Anti Convulsant Trust (In-FACT), suggesting that prescription numbers of sodium valproate for women remain similar to those in 2015.

However, Lord O’Shaughnessey also mentioned the Medicines and Healthcare products Regulatory Agency (MHRA) pregnancy prevention programme, which came in in April 2018. This programme was put together to ensure that girls or women of childbearing age have effective birth control if they are prescribed sodium valproate.

Baroness Blackwood from the Department of Health and Social Care said that the government’s aim is to “reduce and eliminate pregnancies being exposed to valproate”. She said that healthcare professionals are responsible for making women aware of the risks of this medicine and ensuring they are on the pregnancy prevention programme.

Baroness Walmsley added that Philip Lee, chief executive of Epilepsy Action, had stressed the importance of a mandatory discussion of the risks with a health professional for all women with epilepsy on sodium valproate. This is to ensure they can make an informed choice before conceiving. Mr Lee’s comment had followed two surveys in 2016 and 2017 showing that around one-fifth of women were not aware of the risks of this medicine in pregnancy.

She also suggested that community pharmacies have a role to play in ensuring the safe and cost-effective use of medicines and seeking feedback from patients. The debate also saw calls made for compensation to be provided to people who have suffered from unsafe medicines or devices.

Epilepsy Action has said it is pleased that the issues with sodium valproate have been raised in the House of Lords. The organisation said it will continue to campaign to ensure every woman prescribed sodium valproate is aware of the risks.

 

Epilepsy Action advises that women taking this medicine 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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