Austin, TX (PRWEB) May 02, 2011
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.
Topamax is an anti-convulsant used to treat certain types of epileptic seizures. It is also used to prevent migraines. The chemical name for Topamax is Topiramate, and it is sold under the generic name Topiragen.
A scientific study, published in Neurology in 2008, established that taking Topamax significantly increases the risk of birth defects. The published study reviewed 203 pregnancies. The rate of oral cleft birth defects observed was 11 times more common than the normal rate. Due to these and other serious side effects, the United States Food and Drug Administration (FDA) issued a warning for patients taking Topamax. This month, the warning was raised to Category D, which means there is “positive evidence of human fetal risk.”
The Texas based law firm of O’Hanlon, McCollom & Demerath is now accepting clients from across the United States who may have suffered birth defects due to a dangerous side effect of Topamax. The firm is equipped to handle even the most complex drug products liability claim. If you suspect your family has a Topamax lawsuit due to an injury such as cleft palate or cleft lip, and you need to talk to a seasoned team of professionals, please visit our website.