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As I have previously reported, the FDA has required the makers of Topamax and generic topiramate to update their warning label regarding use of the Topamax drug during pregnancy. The usage of Topamax during pregnancy, can cause children to be born with a cleft lip or cleft palate. And shockingly enough, it appears that this particular birth defect information has been available for years and that Topamax birth defect side effects may cause malformations. Folks, the manufacturers have failed to adequately research their medication or warn consumers and doctors.

The medical journal Neurology, in July 2008, reported that pregnant women who received Topamax for epilepsy treatment, faced an increased incidence of babies with birth defects or congenital malformations. Topamax use during pregnancy was linked to babies born with cleft lip or cleft palate at a rate 11 times higher than would be expected in the general population and babies born with genital defects at a rate 14 times higher than would be expected.

Apparently this research and other post-marketing data was available to the Topamax manufacturers, and they failed to warn women about the risks of pregnancy and Topamax. If proper warnings was provided, these women could have chosen to take a different drug or taken contraception to ensure they did not become pregnant while on Topamax.

According to reports made to the North American Antiepileptic Drug Pregnancy Registry, the prevalence of oral clefts in children born to mothers who used Topamax while pregnant was 20 times higher than among women who did not take any antiepiletic drug. When compared to other epilepsy drugs, the prevalence of birth defects was still 2-3 times greater with Topamax pregnancy use.

Because of the drug makers’ decision not to disclose this important information, there are many children who have experienced birth defect problems. Compensation may be available through a Topamax cleft palate or Topamax lip lawsuit for children who were exposed to the drug before they were born.

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