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 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/ucm

350866.htm