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Patient safety

House of Commons to discuss the use of valproate in pregnancy

The UK Parliament is set to hold a debate on the use of epilepsy drug valproate in pregnancy on 19 October 2017, after campaigners and MPs called for a discussion on the drug’s risk.

Norman Lamb, MP and chair of the House of Commons Science and Technology Committee, who was among those calling for the debate, told The Pharmaceutical Journal that the issue was “one of most severe health scandals in history”.

“For more than 40 years, women with epilepsy have been taking the drug with no real idea about the risk to their unborn child,” he said.

“Health regulators decided at the time to keep these hidden from patients, and there has been ongoing complacency about alerting women to the potential risk. The consequences for thousands of children and their families have been life-changing.”

He said it was “critically important that the government acts to ensure that the warnings are getting through”.

He also called for the government to provide financial support to all affected.

“I am strongly of the view that there should be financial assistance for people who have suffered as a result of this extraordinary failure,” he said.

He added that the moral imperative to act was “overwhelming”.

In September 2017, the European Medicines Agency (EMA) held its first ever public hearing into the safety of the drug.

Jurate Svarcaite from the Pharmaceutical Group of the European Union, representing community pharmacists, said pharmacists could play an increased role in raising awareness about the risks of valproate in women of childbearing age.

Results of a recent survey published by epilepsy patient charities, including the Epilepsy Society, Epilepsy Action and Young Epilepsy, show that almost 70% of women who were given valproate to treat their epilepsy had not received new UK safety warnings about the dangers of taking it during pregnancy.

According to the Medicines and Healthcare products Regulatory Agency, sodium valproate carries a 10% risk of physical abnormalities in unborn babies. Babies exposed to the drug in the womb also have a 40% risk of developing autism, low IQ and learning disabilities, it says.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203736

Readers' comments (1)

  • I took Valproate during pregnancy, was reassured it would be fine. My son is disabled for life.
    I'm a member of MHRA Valproate stakeholders network and have given evidence at EMA in 2014 & 2017.

    I have been really pleased with the positive input from pharmacists and the inclusion of the profession in these meetings.

    I am concerned that pharmacists are being asked to take on more work with no additional funding by government.

    The promotion of home delivery services will offer a good service to some but if pharmacists are being given responsibility in drug safety updates like the valproate toolkit then patients will have to see their pharmacist face-to-face.

    Additional funds need to be made available as so many community pharmacies are forced to close.

    Thank you for all your help in promoting and supporting the valproate toolkit.

    #FACSaware

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