1. FDA warns pregnant women to not use certain migraine
prevention medicines
The U.S. Food and Drug Administration is alerting health care providers and patients
that medications including and related to valproate sodium can cause decreased IQ
scores in children whose mothers took the medication during pregnancy. Therefore,
these drugs are being contraindicated for (should never be used by) pregnant women for
the prevention of migraine headaches. Valproate products include valproate sodium
(Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic
acid (Depakene and Stavzor), and their generics.
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).
Medicines that contain valproate already have a boxed warning for fetal risk, including
birth defects. The recently published Neuro developmental Effects of Antiepileptic
Drugs (NEAD) study found further evidence of the IQ risk, leading to today’s
strengthened warnings.
“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.
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

2. pregnant should not use valproate unless it is essential to managing their medical
condition. Women who are pregnant, or who become pregnant while taking one of these
medications, should talk to their health care professional immediately. Women
should not stop taking their medication without talking to their health care professional
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.
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’s 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.
In a June 2011 alert, the FDA released interim results from the NEAD study that showed
reduced cognitive test scores in these valproate-exposed children at age 3, and at that
time the drug labels were updated.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). Valproate products will remain category D for the other two approved
indications, epilepsy and manic episodes associated with bipolar disorder.
For more information’s log onto:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm35
0866.htm