Exposure To Epilepsy Drug Depakote During Pregnancy Can Increase Risk Of Mental Defects In Newborns, Study Says

Main Category: Epilepsy
Also Included In: Pediatrics / Children's Health;  Women's Health / Gynecology;  Pregnancy / Obstetrics
Article Date: 08 May 2007 - 21:00 PST

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Women with epilepsy who took the seizure drug valporate, which is marketed by Abbott Laboratories under the brand name Depakote, while pregnant increased their risk of having an infant with mental defects, according to a study presented Thursday at the annual meeting of the American Academy of Neurology in Boston, the New York Times reports.

Kimford Meador, professor of neurology at the University of Florida, and colleagues examined 185 infants at age two using standard IQ measures. The mothers of the children had taken either Depakote, GlaxoSmithKline's Lamictal, Novartis' Tegretorl or Parke-Davis' Dilanten (Carey, New York Times, 5/4). The average IQ of the children whose mothers had taken Depakote was 81, compared with an average of 96 for children in the Tegretol group, 94 for the Lamictal group and 95 for the Dilantin group (Gellene, Los Angeles Times, 5/4). After adjusting for the mothers' IQ scores, the researchers found that the two-year-old children who had been exposed to Depakote scored seven to eight points lower on IQ tests than children of mothers who had taken other seizure medications (New York Times, 5/4).

A score of 100 on the IQ test is average and below 70 is considered mentally retarded, according to researchers. Twenty-four percent of children whose mothers took Depakote had IQs below 70, compared with 13% for Tegretol, 11% for Lamictal and 12% for Dilantin. According to researchers, about 2% of all children have IQs below 70. According to the Los Angeles Times, Depakote also is used to treat migraines and some psychiatric conditions, such as bipolar disorder.

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Meador said that the NIH-funded study did not support a conclusion that all four drugs might cause mental retardation (Los Angeles Times, 5/4). However, he said, "In all, it is compelling evidence that [Depakote] should not be used as a first-line choice for treatment in pregnant women" (New York Times, 5/4). Meador said that women who must take Depakote because they do not respond to other drugs should take the lowest possible dose if they become pregnant. He also urged pregnant women to remain on their epilepsy medication because a seizure could be harmful to them and their fetuses (Los Angeles Times, 5/4).

Other researchers said the findings should be considered preliminary because IQ measures are less reliable in two-year-olds than in older children, the Times reports. Laureen Cassidy, a spokesperson for Abbott, said that for many women, "Depakote may be the only effective seizure control medication, and that decision should be made thoughtfully between physician and patient to fully evaluate the risk verses benefit of treatment." Depakote's label now states that the drug "has been associated with birth defects in children of women who have taken it while pregnant," the Times reports. Researchers plan to continue tracking children through age six (New York Times, 5/4).

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