Some advice on valproate / depakote use. JR
Valproate in the treatment of epilepsy in girls and women of childbearing potential
Summary
This document provides guidance on the use of valproate in girls and women of childbearing age from a joint Task Force of the Commission on European Affairs of the International League Against Epilepsy (CEA-ILAE) and the European Academy of Neurology (EAN), following strengthened warnings from the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) of the European Medicines Agency (EMA), which highlight the risk of malformations and developmental problems in infants who are exposed to valproate in the womb. To produce these recommendations, the Task Force has considered teratogenic risks associated with use of valproate and treatment alternatives, the importance of seizure control and of patient and fetal risks with seizures, and the effectiveness of valproate and treatment alternatives in the treatment of different epilepsies. The Task Force's recommendations include the following:
(1) Where possible, valproate should be avoided in women of childbearing potential.
(2) The choice of treatment for girls and women of childbearing potential should be based on a shared decision between clinician and patient, and where appropriate, the patient's representatives. Discussions should include a careful risk–benefit assessment of reasonable treatment options for the patient's seizure or epilepsy type.
(3) For seizure (or epilepsy) types where valproate is the most effective treatment, the risks and benefits of valproate and other treatment alternatives should be discussed.
(4) Valproate should not be prescribed as a first-line treatment for focal epilepsy.
(5) Valproate may be offered as a first-line treatment for epilepsy syndromes where it is the most effective treatment, including idiopathic (genetic) generalized syndromes associated with tonic–clonic seizures.
(6) Valproate may be offered as a first-line treatment in situations where pregnancy is highly unlikely (e.g., significant intellectual or physical disability).
(7) Women and girls taking valproate require regular follow-up for ongoing consideration of the most appropriate treatment regimen.Close the feedba
Key Points
Recommendations for the Use of Valproate in the Treatment of Epilepsy in Girls and Women of Childbearing Potential
- The choice of treatment for girls and women of childbearing potential should be that of a shared decision between clinician and patient, and be based on a careful risk–benefit assessment of reasonable treatment options for the patient's seizure or epilepsy type.
- Given the risks associated with exposure in utero, valproate should be avoided wherever possible as initial treatment of epilepsy in girls and women of childbearing potential.
- Valproate should thus generally not be used for treatment of focal epilepsies, and withdrawal of valproate or switch to treatment alternatives should be considered for women of childbearing potential who are established on treatment with valproate for focal seizures and who are considering pregnancy.
- In cases where valproate is considered the most appropriate option (e.g., some idiopathic/genetic generalized epilepsies), every female patient and the parents of a female child must be fully informed of the risks associated with valproate use during pregnancy as well as of the risks and benefits of treatment alternatives.
- When used in girls and women of childbearing potential, valproate should be prescribed at the lowest effective dose, when possible aiming at doses not exceeding 500–600 mg/day, although, at times, higher doses may be necessary to attain seizure control.
- Women of childbearing potential who are not planning pregnancy and who continue treatment with valproate should utilize effective contraception methods or otherwise ensure that unplanned pregnancies can be avoided.
- It is generally not advisable to switch from valproate to another treatment in women who discover that they are pregnant while on valproate.
- Women should be informed about the possibilities and limitations of prenatal screening, which may detect major malformations but cannot identify children whose neurodevelopment will be affected.
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