The Medicines and Healthcare products Regulatory Agency (MHRA) have published a Drug Safety Update and updated safety and educational materials to support healthcare professionals and patients to implement the existing regulatory requirements.
The Medicines and Healthcare products Regulatory Agency (MHRA) have published a Drug Safety Update and updated safety and educational materials to support healthcare professionals and patients to implement the existing regulatory requirements.
The updates reflect:
- precautionary advice on the potential risk of neurodevelopmental disorders in children fathered by men taking valproate around the time of conception
- a risk of lower weight at birth for the gestational age in children exposed to valproate during pregnancy
Updated safety and educational materials
The following new or updated safety and educational materials are now available on the MHRA website:
- Annual Risk Acknowledgement Form for female patients
- Risk Acknowledgement Form for male patients starting valproate
- Patient guide for women
- Patient guide for men
- Patient card
- Booklet for healthcare professionals
- Valproate dispensary poster
We have sent an email update to all pharmacy technicians and pharmacists to highlight the new materials.
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