Valproate Migraine Drugs During Pregnancy Bad For Baby's IQ

Using migraine prevention valproate sodium drugs during pregnancy can cause offspring to have a lower IQ, the US Food and Drug Administration (FDA) warned yesterday.

Sodium valproate is an anticonvulsant prescribed by doctors for the treatment of migraine, bipolar disorder, PTSD (post-traumatic stress disorder), anxiety disorder, anorexia nervosa and epilepsy.

The FDA is contraindicating valproate drugs for the prevention of migraine headaches for pregnant women. Contraindicated means it should never be used.

Examples of valproate products include: Valproate sodium - DepaconDivalproex sodium - Depakote, Depakote CP, and Depakote ERValproic acid - Depakene and StavzorPlus all related genetic productsDrugs with valproate in them already have a boxed warning for birth defects. The NEAD (Neurodevelopmental Effects of Antiepileptic Drugs) study identified a further risk - that valproate medications can lower the baby's IQ if taken during pregnancy. The link to lower IQ was, in fact, mentioned several years ago (see below). The NEAD study followed over 300 children in the USA and UK who were born to mothers with epilepsy who were taking any of the following antiepileptic drugs - valproate, phenytoin, lamotrigine, or carbamazepine. Enrollment began in 1999 and took place at 25 centers in the USA and UK. The researchers published initial findings in April 2009 in NEJM (New England Journal of Medicine linking valproate usage during pregnancy to lower IQ in offspring.

Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said yesterday:

"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."

As far as pregnant patients with bipolar disorder are concerned, the FDA says that valproate medications should only be considered if other drugs have failed to control symptoms or are otherwise unacceptable.

The FDA wrote in an online communiqué:

"Women who can become pregnant should not use valproate unless it is essential to managing their medical condition."

If you are pregnant, or have just become pregnant and are on a valproate drug, talk to your doctor immediately, the FDA advises. Do not stop taking your medication without checking with a health professional first. Stopping treatment abruptly can cause serious and even life-threatening complications for both the mother and the developing fetus/embryo.

If you are of childbearing age and sexually active and take a valproate product, you should use effective birth control.

Experts do not know when exactly during pregnancy valproate exposure can cause a lowering of IQ in the fetus. In the NEAD study, the mothers were exposed to antiepileptic medications throughout their pregnancies.

These new recommendations come after FDA experts examined the final results of the NEAD study, which showed that at the age of 6 years children whose mothers had taken valproate drugs for epilepsy while pregnant had lower IQs compared to mothers who took the other drug for epilepsy. There was a difference of between 8 and 11 points in the children's IQ, depending on the antiepileptic drug.

Valproate drug labels were updated in 2011 when the FDA released interim results of the NEAD study which showed a reduction in the IQs of children aged 3.

The FDA says it is liaising with drug manufacturers to make changes to the drug labels to reflect these new data 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)".

Researchers from Aarhus University Hospital, Aarhus, Denmark, reported in JAMA (Journal of the American Medical Association), April 2013 issue, that pregnant women who take valproate raise the risk of giving birth to a child with autism.

The authors added "..the absolute risk of autism spectrum disorder was less than 5 percent, which is important to take into account when counseling women about the use of valproate in pregnancy."

Written by Christian Nordqvist
Copyright: Medical News Today
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