The European Medicines Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC) are recommending new measures to avoid exposure of babies to valproate medicines in the womb. Babies exposed are at risk of malformations and developmental problems.
Main measures recommended by the PRAC
Where licensed for migraine or bipolar disorder
- In pregnancy – valproate must not be used.
- In female patients from the time they become able to have children – valproate must not be used unless the conditions of a new pregnancy prevention programme (see below) are met.
- In pregnancy – valproate must not be used. However it is recognised that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment (with appropriate specialist care) in pregnancy.
- In female patients from the time they become able to have children – valproate must not be used unless the conditions of the new pregnancy prevention programme are met.
- The PRAC has also recommended that the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy. In addition to boxed text, this may include a symbol/pictogram, with the details to be adapted at national level.
- A patient reminder card will also be attached to the outer package for pharmacists to discuss with the patient each time the medicine is dispensed.
- Companies that market valproate should also provide updated educational materials in the form of guides for healthcare professionals and patients.
New valproate pregnancy prevention programme
Assessing patients for the potential of becoming pregnant, and involving the patient in evaluating her individual circumstances and supporting informed decision making, pregnancy tests before starting and during treatment as needed, counselling patients about the risks of valproate treatment, explaining the need for effective contraception throughout treatment, carrying out reviews of treatment by a specialist at least annually, introduction of a new risk acknowledgement form that patients and prescribers will go through at each such review to confirm that appropriate advice has been given and understood.
Read the full press release.