Dear Healthcare Professional Letter on the risk of abnormal pregnancy outcomes associated with the use of valproate (Depakine Chrono)
Sanofi-aventis Croatia d.o.o., in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the risk of abnormal pregnancy outcomes associated with the valproate use (sodium valproate, valproic acid, fixed combination sodium valproate/valproic acid and valpromid are concerned), upon completion of the review of the available data in the entire Europe.
- Children exposed to valproate in the womb are under high risk of serious disorders in their development (in 30-40% of cases) and/or congenital malformations (in about 10% of cases).
- Valproate must not be prescribed to female children, female adolescents and women in reproductive age or pregnant women, except in the cases where other therapies are inefficacious or patients do not tolerate them.
- The valproate treatment should be initiated and supervised by a doctor experienced in treatment of epilepsy or bipolar disorders.
- The use of the valproate treatment should be carefully reviewed against the risk at the first prescribing, at routine examinations/checks during the treatment and after the female child enters into puberty or if the patient plans a pregnancy or becomes pregnant.
- Healthcare professionals are obliged to ensure that all patients are informed and that they understand:
- the risks associated with the valproate use in pregnancy
- the need for use of efficacious contraception
- the need for regular checks during the treatment
- the need to urgently consult their doctor in the case of planning a pregnancy or established pregnancy
Valproate is used in the epilepsy and bipolar disorders treatment. In several EU member states, but not in Croatia, valproate is used for migraine prevention.
New warnings and the valproate use restriction are the result of the EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC). After the completion of the review the PRAC concluded that due to the risks of congenital malformations and problems in children exposed to valproate in the womb during pregnancy, stricter restrictions of use should be introduced. The PRAC also recommends that that valproate should not be used in the epilepsy or bipolar disorders treatment in girls and women that may become pregnant or already are pregnant, except in the case where other medicines are inefficient or are not tolerated by the patient.
The summary of product characteristics and package leaflet will be updated to include the information substantiating the current understanding of the available evidence to clarify entirely the information.
The educational material will be available to healthcare professionals and patients to provide the information on the risks associated with the valproate use in female children, women in reproductive age and pregnant women.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.