The Pharmacoviliance Risk Assessment Committee (“PRAC”) of the European Medicines Agency has this morning announced a recommendation of new measures to avoid or minimise the exposure of sodium valproate/epilim in pregnancies. Click here for the full details.
Key recommendations include:
- In pregnancy, when being used to treat migraine or bipolar disorder, sodium valproate “must not be used”
- In pregnancy, when being used to treat epilepsy, sodium valproate must not be used save in rare cases where it is the only effective drug for that patient.
- For female patients of child bearing age, sodium valproate must not be used unless conditions of a new pregnancy prevention programme are met.
- A visual warning on the outer packaging of valproate medicines.
- A patient reminder card attached to the outer packaging, for pharmacists to discuss with the patient on each dispensing.
- Companies marketing valproate to provide updated educational materials for both healthcare professionals and patients
- Companies marketing valproate to carry out additional studieson the risks posed by sodium valproate.
- General recommendation to strengthen restrictions on use
Speaking with epilepsy patients for whom we have already been instructed, it is clear that the epilim tooklit has not been adequately distributed or made known to women who are being treated with epilim.
It is hoped that the EMA recommendations today will be followed up by swift action to raise awareness of the risks of sodium valproate and to support those who are already living with the adverse consequences of the medicine.
For any queries in relation to the above, please contact Sam Saarsteiner, head of our litigation team at 01-6344680 or email email@example.com.