The FDA is warning pregnant women not to use certain migraine prevention medicines, especially Valproate products, because exposure to these drugs in utero can lower a child's IQ.
Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics. These products are approved by the FDA for the prevention of migraine headaches; treatment of epilepsy (seizures); and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder).
There already exists a boxed warning for fetal risk for Valproate products. The drugs' labels will now be revised to reflect the new information about the IQ risk in children exposed to Valproate.
The NEAD (Neurodevelopmental Effects of Antiepileptic Drugs) study results provided evidence of the IQ risk.
According to the study results, 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, said the FDA in a statement.
The FDA noted that it will also change the pregnancy category assigned to Valproate products for prevention of migraine headaches to Category X from Category D.
Depending upon how safe a drug is for use during pregnancy, a drug is classified as A, B, C, D and X. Category X means that the drug's risks outweigh the drug's benefits for the intended use in pregnant women while Category D means that the drug's benefits outweigh its risks.
However, for the other two approved indications namely, epilepsy and manic episodes associated with bipolar disorder, Valproate products will continue to be listed under Category D, the FDA noted.
by RTT Staff Writer
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