Topamax Birth Defect Study Leads to Increased FDA Warnings Says O’Hanlon, McCollom and Demerath

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The attorneys at O’Hanlon, McCollom and Demerath announce free legal consultations to mothers who took Topamax during pregnancy and gave birth to children with birth defects such as cleft lip or cleft palate. The FDA recently strengthened their warning for Topamax stating that expecting mothers taking the drug are 20 times more likely to suffer a birth defect.

O’Hanlon, McCollom and Demerath reports: according to a 2008 scientific study published in Neurology, taking Topamax during pregnancy significantly increases the risk of cleft lip and palate birth defects. The article, “Topiramate in Pregnancy: Preliminary Experience from the UK Epilepsy and Pregnancy Register,” reviewed 203 pregnancies. Of the 178 babies born, 16 had major birth defects. Four of the babies had oral clefts – 11 times more prevalent than the normal rate.

High incidents of oral clefts from women taking Topamax were reported to the UK Epilepsy and Pregnancy Register, as well as the North American ARF Pregnancy Registry. Due to these and other serious side effects, the United States Food and Drug Administration (FDA) requested a review of Topamax birth defects on January 21, 2011. Federal regulators asked Vivius, Inc. to review potential reports of oral birth defects among children of women who took Topamax during pregnancy.

As a result of this and other studies, FDA issued an increased warning for patients taking Topamax. This has led to a dramatic increase in Topamax lawsuit filings. The FDA notified healthcare providers and patients of an increased risk of development of oral clefts (cleft lip or cleft palate) in infants born to women treated with Topamax during pregnancy. Due to updated human data that shows an increased risk for oral deformities, the warning was raised to Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk.

Patients who took Topamax during pregnancy can request a free legal consultation from the law firm of O’Hanlon, McCollom and Demerath – the firm has experienced Topamax Lawyers who are working to hold these manufacturers accountable for the damages caused by this dangerous drug.


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