Topamax Birth Defect Study Leads to Increased FDA Warnings
Tuesday, 10 May 2011 20:54
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.
Austin, TX (PRWEB) - 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.
Children with Birth Defects May Have Topamax Lawsuit
Monday, 02 May 2011 20:54
In March 2011, the U.S. Food and Drug Administration strengthened its warning against the anti-consulant drug, Topamax, because new data suggests an increased risk of birth defects such as cleft palate or cleft lip.
Austin, TX (PRWEB) - O’Hanlon, McCollom & Demerath reports that the U.S. Food and Drug Administration recently strengthened its warning on Topamax because new data suggests an increased risk of birth defects such as cleft palate or cleft lip if used during pregnancy. Oral clefts occur when parts of the lip or palate fail to completely fuse together during gestation. The defect can result in a small, notched lip or in extreme cases, an open groove that extends from the nose to the roof of the mouth. Cleft lip and cleft palate birth defects can cause problems eating and talking, and can also increase the risk of ear infections.
