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Topamax and birth defects: “We are not out of the woods [yet]”

In yesterday’s Journal of the American Medical Association, Danish doctors published one of the largest studies ever to examine the issue of epilepsy drugs (including Topamax) and birth defects. The study found that use of newer antiseizure drugs during the first trimester of pregnancywas not associated with an increased risk for major birth defects.” (WedMD)

But this lowered risk does not apply to Topamax. Birth defects remain a risk for women of childbearing age who take Topamax (or Topamirate, the generic version). The FDA warned in March that use of Topamax early in pregnancy was associated with an increased risk for cleft palatesin newborns.

About 100 of the 800,000 women included in the Danish registry study took Topamax. “We cannot conclude anything or make any recommendations on [Topamax], based on this study,” researcher Anders Hviid said. Researchers found that 4.6% of women who took Topamax and 3.7% to 4% of women who took Lamictal delivered babies with major birth defects.

Epilepsy specialist Dr. Jacqueline French told WebMD the findings are “reassuring because if the rates of fetal malformation were as high as with Depakote, even with the small sample sizes in this study we would see it.”

As far as Topamax and older anti-epilepsy drugs are concerned, Dr. French warns that “the findings are not reassuring enough to say that we are out of the woods with all of these drugs.”

Weitz & Luxenberg has helped many families cover the costs of the congenital conditions their children suffered as a result of the mother taking medications with dangerous side effects. We look forward to further advances that lessen these dangerous side effects, and in the meantime, we are committed to helping the victims of dangerous drugs and medical devices seek compensation.

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