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Collection of information and guidance for patients and for healthcare professionals on the reproductive risks of valproate and new safety measures introduced to reduce these risks.
Information about the risks of taking valproate medicines during pregnancy.
We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study...
New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired...
Other effective medicines are available for epilepsy and bipolar disorder and valproate should only be used if these don’t work or aren’t suitable for an individual patient
Guidance for specialists for initiation of valproate in female patients and for annual review and pregnancy testing to support adherence to pregnancy prevention requirements during the pandemic.
The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advice from the Commission on Human Medicines...
No one should stop taking valproate without advice from their healthcare professional
The new safety measures being introduced in UK are for male and female patients
No action is currently needed from patients. No one should stop taking valproate without advice from their healthcare professional.
Public Assessment Report of review of valproate safety data and expert advice on management of risks.
Patients to receive the latest valproate safety information with every pack, following changes to the Human Medicines Regulations, 2012
Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
Guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs).
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regulatory measures for valproate.
How we engage and involve patients and the public in our regulatory decision-making.
Public consultation on proposals to allow pharmacists to dispense prescription medicines in original packaging, in particular those containing sodium valproate.
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