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:
The EMA made the following specific recommendations:
- If possible, an alternative to valproic acid should be used in women of reproductive age
- If valproic acid is the only option, women should use effective contraception and should be closely supervised.
- Doctors who prescribe valproic acid to women of reproductive age must review the reproductive risks associated with this drug and must clearly explain the reason for choosing valproic acid over other options.
- Women taking valproic acid should also take 4 mg of folic acid daily to reduce the risk of birth defects in the setting of unplanned pregnancy.
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