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Epilepsy Society praises Government decision to review handling of concerns around sodium valproate

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Epilepsy Society praises Government decision to review handling of concerns around sodium valproate

Epilepsy Society's chief executive Clare Pelham has praised the Government's decision to announce a forward-looking review that will address the way the healthcare system has handled the concerns of patients in its care and make certain that lessons are learned and history does not repeat itself.

Today in parliament, health minister Jeremy Hunt, announced a review into the way concerns over side effects from three NHS treatments, including sodium valproate, have been handled by the healthcare system.

Jeremy Hunt in parliament

In an honest and apologetic statement he acknowledged that the response from those in authority to serious health concerns raised by charities and patient groups concerning sodium valproate, Primodos and vaginal mesh implants has not always been good enough.

He told the Commons: 'Sometimes the reaction has felt too focused on defending the status quo, rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse.

'So today, in addition to practical steps for each of the three cases, I am setting out plans to establish a fairer, quicker and more compassionate way to address issues when they arise, bringing different voices to the table from the start and giving individuals and their families a clear path to answers and resolution.'

Jeremy Hunt

Mr Hunt said the outcome of the EU review into sodium valproate, expected in March, would 'strengthen our regulatory position' around the prescribing of this drug. In preparation, the Government has tasked system leaders with delivering a rapid, co-ordinated response.

In direct response to calls from patients, he said the Government would be:

  • introducing a new warning symbol on valproate packaging
  • updating National Institute for Health and Care Excellence guidance on valproate
  • pushing for valproate to be contraindicated for women of childbearing potential not using effective contraception
  • strengthening alerts across all GP systems and community pharmacy systems
  • and, for those women for whom valproate is an effective treatment, offering stronger and more tailored advice on risks and contraception.

You can read the full Hansard report here.

Or watch Jeremy Hunt on Parliament Live here.  Medicines and Medical Devices Safety Review12:48:06

Epilepsy Society responds

Epilepsy Society’s chief executive Clare Pelham said: "We are delighted.

"In a week when there have been concerns about some charities, we welcome the Government's responsiveness to the issues that we have raised alongside affected families where mothers have taken sodium valproate during their pregnancy.

"This is an example of a Government engaging constructively with women with epilepsy, and acting on their concerns. As a member of the Expert Working Group on Sodium Valproate, I am delighted to hear of Jeremy Hunt's support for better labelling and mandatory annual conversations between a woman prescribed sodium valproate and her doctor reminding her of the risk to her unborn baby should she become pregnant-with a signed record of that conversation.

Clare Pleham

"This drug has been licensed since 1974, and we have been campaigning, with victims' groups, for these measures for many years.

"These changes are overdue, and we welcome the Government's commitment to implement them. Over 28,000 women with epilepsy take this drug every day and these measures (when implemented) should dramatically reduce the number of babies born with avoidable disabilities.

"Our hearts go out to all the mothers since 1974 who have taken sodium valproate during their pregnancy in ignorance of the risk to their unborn baby. It is a tragedy for any baby to be born with an avoidable disability.

"We are therefore impressed that the Government has decided to set up a Review led by Baroness Cumberlege and  to learn lessons. And pleased with Jeremy Hunt's commitment that the Baroness will be reporting to Ministers not to the MHRA. 

"It is a genuinely wise and reflective step by the Government to address, not only these immediate and serious women's health issues, but also to consider how we arrived at the position where the voices of affected families were not heard over tens of years by senior doctors or medical quangos or the Department of Health. And when they were heard, or their concerns raised, they were marginalised or disregarded or diverted into bureaucratic swamps of inertia.

"We shall cooperate to the max with the Review."