The Food and Drug Administration issued a warning on Monday advising pregnant women not to take valproate sodium products. Studies have shown that the medication can cause decreased IQ scores in children whose mothers took the medication during their pregnancy, the FDA said.
Valproate medications are approved to prevent migraine headaches, treat epilepsy and treat manic episodes associated with bipolar disorder. Products under the warning include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor) and their generics.
"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," Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a press release.
The FDA added that women who may become pregnant should not use the product unless it is vital to controlling their medical conditions, and only if there is no other alternative.
The agency will change valproate products' designation from category D -- which mean the benefits outweigh the drug's risks -- to category X -- meaning the drug's risks outweigh the benefits -- for pregnant women who take the medication for migraines.
The American Headache Society listed valproate sodium as one of the seven kinds of preventative migraine treatments in April 2012, adding that almost 40 percent of migraine sufferers could lower the frequency of their condition by taking one of the medications.
Valproate will remain a category D for its anti-epileptic indications and for treatment of manic episodes.
A new study called Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) that showed that the medication could lower IQ if taken prenatally led the FDA to issue its new warning. Children whose mothers had used the medication had an IQ score eight to 11 points lower at age 6 than those whose mothers used other anti-epileptic drugs.
Another study last month showed that valproate was linked to anMothers who used the medication during pregnancy had a five times higher risk of having a child diagnosed with an autism spectrum disorder compared to children whose mothers did not take the drug.
Medications with valproate are already labeled with a warning stating they can cause birth defects and other fetal risks. The label was added when preliminary results issued in June 2011 from the NEAD study said that the medication could lead to lower intelligence scores by the time the child was 3 years old.