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Study Reports Detrimental Side Effects of Antiepileptic Drug Valproate on Fetuses

Update Date: Mar 20, 2013 12:16 PM EDT

In a long term study evaluating the effects of antiepileptic drugs taken by pregnant women, the findings reveal that one of the four antiepileptic drugs, valproate, can cause cognitive development issues in the children exposed in utero. This study, known as the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD), started in 1999 and looked at the effects of carbamazepine, lamotrigine, phenytoin or valproate. Pregnant women who suffered from seizures were taking one of the drugs while the effects of these drugs were still unclear.

The researchers of the largest study ever done on the side effects of antiepileptic drugs found that children who were specifically exposed to valproate, also known as Depakote, had a lower intelligence quotient, IQ, by the age of six. The lead author of the study and professor of neurology at Emory University School of Medicine, Kimford Meador, MD and colleagues concluded that children who were exposed to the particular antiepileptic drug had an IQ that was seven to 10 points lower than the children that were exposed to the other three antiepileptic drugs.

"Data published at ages 3 and 4.5 showed similar results in cognitive impairment. Age 6 IQ was our primary outcome goal because it is standardized and predictive of school performance," Meador stated.

The research team observed pregnant women who were taking the drugs and followed up on their children every year when they first turned two to six. The children were given cognitive exams that measured performance levels.

"These findings consistently show a substantial loss of developmental abilities for these children. Women of childbearing age who have epilepsy should talk with their doctors about their options, and possibly test the safer medications prior to pregnancy to find out if they work," Meador added.

Valproate is effective in treating primary generalized seizures resulting from epilepsy, and is often used to treat migraines and bipolar disorder. For some women, valproate is the only drug that can successfully treat their conditions. Due to this case, the researchers of the study stress that pregnant women who are currently taking valproate should not discontinue their usage. Researchers also remind pregnant women that suffering from an actual seizure might result in a more detrimental situation due to the trauma that seizure inflicts on the body than taking the drug.  

Meador will do a follow up study with Page Pennell, MD from Harvard in which they will study the risks of these antiepileptic drugs on mother and child in 350 pregnant women with epilepsy. They will also look at the effects of the drugs on 100 non-pregnant women with epilepsy. Another 100 pregnant women will serve as the control group. The study is called the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) and is being funded by the National Institutes of Health.

The study was published in Lancet Neurology

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