MHRA issues materials and advice relating to valproate

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MHRA issues materials and advice relating to valproate

February 18, 2016

New communication materials have been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) to increase awareness and support discussions of the risks of valproate, with women of childbearing potential and girls. This follows the MHRA’s drug safety update on new information and strengthened warnings relating to valproate last month.

The MHRA has issued a booklet for healthcare professionals and a checklist for patients and prescribers to inform them of the risks associated with the use of valproate by females of childbearing potential and during pregnancy. There is also a patient card and a patient guide available.

The MHRA has issued specific advice for pharmacists with the launch of the new resources:

  • Whenever you dispense a medicine related to valproate for a woman of childbearing potential or girl, give her a patient card, unless she confirms that she already has one;
  • Encourage her to read the card and enter her name and date to reinforce her own accountability to consider the information it contains;
  • If you manage dispensing services in your organisation, ensure that processes are in place to allow these requirements to be met; and
  • Please continue to report any suspected side effects to valproate or any other medicine on a Yellow Card (please also see MHRA’s guidance on reporting side effects experienced by the woman or child to medicines taken during pregnancy).

Later this year, medicines containing valproate will include a warning on the outer packaging to advise on the risk of adverse pregnancy outcomes.



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