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. This follows a public consultation that took place recently at the EMA offices in London with IBE participating. Representing IBE were Martin Brodie, President who made an oral presentation, and Caroline Morton, Vice President Europe.
For people with epilepsy, the main recommendations are as follows:
- Valproate must not be used where the patient is pregnant. However, it was 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.