May 18th 2013 00:55
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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 - Depacon
Divalproex sodium - Depakote, Depakote CP, and Depakote ER
Valproic acid - Depakene and Stavzor
Plus all related genetic products
Drugs 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).
Valproate link to lower IQ in kids reported in 2009
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.
Avoid valproate during childbearing age if possible
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.
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