Pregnant women warned away from certain migraine prevention medicines
The meds can cause decreased IQ scores in unburn children, FDA says
Saturday, May 11, 2013
There are some drugs that are best not used by pregnant women.
To that list you can ad valproate products for the prevention of migraine headaches. Among them are valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor) and their generics.
The U.S. Food and Drug Administration (FDA) warns that these medications cause decreased IQ scores in children whose mothers took the medication during pregnancy.
“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
Valproate products have several FDA-approved uses including: prevention of migraine headaches; treatment of epilepsy (seizures); and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder).
These medications already have a boxed warning for fetal risk, including birth defects. The recently published Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study found further evidence of the IQ risk, leading to the strengthened warnings.
The strengthened recommendations are based on the final results of the NEAD study, which showed that children exposed to valproate products in utero had decreased IQ at age 6 when compared to children who were exposed to other antiepileptic drugs.
The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the antiepileptic drug.
It is not known if there is a certain time period during pregnancy when valproate exposure can result in decreased IQ. The women in the NEAD study were exposed to antiepileptic drugs throughout their pregnancies.
The FDA is working with the manufacturers to make changes to the drug labels to reflect this new information and to change the pregnancy category for prevention of migraine headaches to category X (the drug's risks outweigh the drug's benefits for this use) from category D (the drug's benefits outweigh the drug's risks for this use).
For its other approved uses -- bipolar disorder and seizures -- valproate may have some value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable. Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.
What to do
Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their health care professional immediately. They should not stop taking their medication without this consultation because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus.
Women of childbearing age taking valproate products should use effective birth control.
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