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Calls for mandatory action at EMA public hearing into use of sodium valproate during pregnancy

10 Oct 2017

The European Medicines Agency (EMA) held a public hearing on medicines containing valproate in London on 26 September.

The public hearing was part of a safety review by the EMA into the use of sodium valproate in women who are pregnant or of childbearing age.

The full hearing can still be viewed on the EMA website and a summary report can also be accessed.

Epilepsy Action attended the hearing alongside a number of other organisations. The results of the 2017 survey into sodium valproate carried out by Epilepsy Action, Epilepsy Society and Young Epilepsy were presented at the hearing.

Sodium valproate is used to treat some epilepsies, as well as other conditions including bipolar disorder and, in some countries, migraine. This is often prescribed under the brand name Epilim and can be a very effective treatment in epilepsy. However, it has been associated with an increased risk of birth defects and developmental problems in babies born to women taking the medicine during pregnancy.

Epilepsy Action advises that if women are taking sodium valproate and are worried about this, they should speak to their doctor. Women should continue to take their medicines as prescribed unless otherwise told by their doctor.

We summarise some of the key points raised by speakers at the public hearing.

 

Patient representatives, carers and families

Guido Rasi, executive director of the EMA, opened the first ever public hearing as part of a safety review in Europe and welcomed those taking part. He said that this is a step towards better transparency. June Raine, the chair of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in charge of reviewing the safety of medicines, chaired the public hearing.

A number of speakers addressed the hearing, who had been personally affected by issues surrounding this medicine. Many also spoke on behalf of organisations representing others affected by this medicine.

Among the speakers was Catherine Cox from the Fetal Anti-Convulsant Syndrome Association in the UK. She told the hearing that the warnings could and should have been given in 1974, but that a deliberate decision was made not to publish them. She added that there is nothing to lose and everything to gain from making reporting of risks mandatory for girls and women being prescribed valproate.

This message was also echoed by Clare Pelham, chief executive of the Epilepsy Society, who was also speaking on behalf of Philip Lee, chief executive of Epilepsy Action. She called for a change in the way repeat prescriptions are made. She said that repeat prescriptions of sodium valproate should not be made to women of childbearing age for more than 12 months without a face-to-face conversation.

Joanne Cozens, speaking on behalf of the Organisation for Anti-Convulsant Syndromes (OACS) criticised clinical experts from the pharmaceutical company Sanofi, who produce the valproate medicine Epilim. She said they were “complicit in avoidable injury to children” and called on Sanofi to share all the data they have on any adverse effects of the medicine.

Many speakers also expressed concern and disappointment over what was considered poor distribution of the Medicines and Healthcare products Regulatory Agency (MHRA) valproate toolkit. This toolkit was launched in 2016 to help healthcare professionals communicate with people about sodium valproate and the risks it poses in pregnancy.

 

Need mandatory action

A number of medical professionals also addressed the EMA at the public hearing. They included consultant paediatric neurologist Prof Helen Cross, professor of neurology Prof Tony Marson and epilepsy specialist midwife practitioner Kim Morley.

The healthcare professionals speaking at the hearing made the point that sodium valproate is a very effective medicine for some epilepsy types. They added that for some people it is the only medicine that works, stressing also that leaving epilepsy untreated is not an acceptable option.

However, the speakers agreed that women should be well informed by their healthcare professionals of the risks in pregnancy when taking sodium valproate. They also believed that valproate should be avoided, where possible, in girls and women of childbearing age.

Many of the speakers at the hearing called for mandatory action to be taken in order for women to be made more aware of the risks of taking sodium valproate during pregnancy. Some asked that reviews be made mandatory, while others called for medical professionals to have to explain the risks to pregnancy to all women who are being prescribed it.

Philip Lee, chief executive at Epilepsy Action said: “The hearing was an important step towards ensuring all women with epilepsy are fully informed of the risks associated with sodium valproate, ideally before they start a family. We heard moving stories from families who brought to life the devastating reality of not being able to make an informed choice about care and treatment. One woman taking sodium valproate unaware of the potential risks is one too many.

“Although work is already being done to ensure women are aware, it's clear from our research that this is simply not enough. This situation cannot continue. The time for voluntary action has passed and we need to move towards something more mandatory to bring about the changes we’re seeking to make.” 

There is more information on sodium valproate on the Epilepsy Action website.

 

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Almost one-fifth of women taking sodium valproate for epilepsy still not aware of risks in pregnancy, survey shows

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