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New toolkit on risks of valproate during pregnancy

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A new toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy has been launched.

The drug, available in both branded and generic version, is prescribed for epilepsy and bipolar disorder, but is associated with a risk of birth defects and developmental disorders in children.

“It will encourage clinicians to raise the subject proactively and give the best possible advice”

Asha Kasliwal

If valproate is taken during pregnancy, up to 40% of babies are at risk of developmental disorders and approximately 10% are at risk of birth defects.

The toolkit is intended to address concerns that the risks of valproate are “not being adequately explained” to female patients, said the Medicines and Healthcare products Regulatory Agency.

The MHRA also strengthened warnings on the risks of valproate in pregnancy last year.

The toolkit includes a credit card sized patient card to be issued by pharmacists, booklets for healthcare professionals and for patients together with a checklist of important questions and discussion points to be kept with the patient’s file.

The MHRA is asking relevant healthcare and mental health professionals to use the toolkit to help facilitate discussion of the risks with their patients.

Dr Sarah Branch, deputy director of the MHRA’s vigilance and risk management of medicines division, said: “The warnings on the risks of valproate in pregnancy were strengthened last year.

“We want to ensure that women and girls have the latest information about the risks of developmental disorders and birth defects in children exposed to valproate during pregnancy,” she said. “This new toolkit supports healthcare professionals to give that advice to their patients.

“This new toolkit supports healthcare professionals to give advice to their patients”

Sarah Branch

She added: “If valproate is the only treatment option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.”

The new toolkit has been welcomed by a raft of charities, including Epilepsy Action, the Epilepsy Society, Bipolar UK, Mind and the Organisation for Anticonvulsant Syndrome.

Dr Asha Kasliwal, vice president of the Faculty of Sexual and Reproductive Healthcare, said: “We believe this toolkit will strongly highlight the risks associated with taking valproate during pregnancy.

“It will encourage clinicians to raise the subject proactively and give the best possible advice regarding highly effective contraception to women taking valproate so that they can avoid unintended pregnancy.”

Mervi Jokinen, practice and standards professional advisor at the Royal College of Midwives, said: “The toolkit will be a valuable resource for midwives and other health professionals involved in the care of pregnant women using the medication.

“It will help to ensure that women taking this medication during pregnancy receive standardised and consistent information wherever they are receiving care,” she said.

She added:”It will also help midwives to provide women with the information about using the medication in pregnancy so that they can make an informed decision about using the medication; one that is right for them and their pregnancy.”


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