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16 May 2016

Minister for Life Sciences reaffirms priority of raising awareness of sodium valproate risk

The Minister for Life Sciences, George Freeman MP, has highlighted the importance of raising awareness of the risks epilepsy drug sodium valproate can pose to pregnancy.

Mr Freeman said the MHRA was working with various bodies to ensure GPs, patients and pharmacists were made aware of their sodium valproate toolkit which highlights the risks around the drug..The toolkit has been produced by the Medicines and Healthcare products Regulatory Agency (MHRA). It includes booklets for healthcare professionals, a reminder card and a guide for women, a checklist for prescribers and clear package labelling carrying a prominent warning about use in pregnancy.

Changes in prescribing sodium valproate

Answering a question raised in a written parliamentary question, Mr Freeman explained that MHRA is conducting a study to track changes in prescribing of valproate to women and girls following the communications to healthcare professionals and patients on the risks of valproate in pregnancy. There are also Europe-wide studies to measure the changes in patterns of prescribing and awareness of the healthcare professionals of the risks. Data will be displayed on a dashboard that will be used to track the impact of the communications on patient and professional awareness over time.

Cat Smith MP posed questions

Mr Freeman’s comments were a written response to questions posed by Cat Smith, Labour MP for Lancaster and Fleetwood around the effectiveness of raising awareness of sodium valproate risks.

Mr Freeman explained that the current priority for MHRA is to ensure that women taking sodium valproate are fully aware of the risks to pregnancy, and that once this was achieved, he would look back at the history of cases to see what lessons could be learnt.

Government has "great sympathy" for families affected

Expressing the Government’s “great sympathy” for families affected by the use of sodium valproate during pregnancy, Mr Freeman outlined the care and support available for the families of children born with a disability. This includes a statutory framework for local authorities to work together to secure services for children and young people – up to the age of 25 – with special educational needs or disability, across education, health and social care.

Research into epilepsy medication for pregnant women

Ms Smith also asked Mr Freeman what support he is providing for research into epilepsy medication for pregnant women. In response, Mr Freeman said: “The Department’s National Institute for Health Research is funding a £1.5 million evaluation of the effectiveness, cost effectiveness and acceptability of dose adjustment strategies in antiepileptic drug management in pregnancy. The report of the evaluation is expected to be published in February 2017.”

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