The European Medicine Agency (EMA)’s Pharmacovigilance and Risk Assessment Committee recently recommended strengthening the restrictions on the use of valproic acid in women of reproductive age.  Over the last few years, we have seen a host of articles documenting the deleterious effects of valproic acid on the developing fetus:

Valproic Acid and the Risk of Major Malformations

Outcomes of Children Exposed to Antiepileptic Drugs in Pregnancy: No Good News for Valproate

Prenatal Valproate Exposure and Risk of Autism Spectrum Disorders

Fetal Exposure to Valproate Associated with Lower IQ

The EMA made the following specific recommendations:

Kimford J. Meador, MD, Stanford University School of Medicine, California, who has conducted several studies in this area, told Medscape Medical News that if adopted, the new restrictions will help reduce the number of children exposed to valproate in utero.

“Given the multiple increased risks of fetal valproate exposure and that about half of pregnancies are not planned, valproate is a poor choice for the large majority of women of childbearing age irrespective of the indication. I agree that its use should be limited to those women who have failed other available therapies, and all women receiving valproate should be fully informed of the risks,” he said.

 

Ruta Nonacs, MD PhD

 

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Restrict Valproate, EMA Committee Urges