Topamax Lawsuits - Vanderhyde and Associates investigating Topamax Litigation for Birth Defect Victims
Law firms are investigating Topamax Lawsuits for possible link to cleft lip birth defects.
- (1888PressRelease) April 08, 2011 - On March 4, 2011 The FDA issued a safety announcement regarding an increased risk for the development of certain craniofacial defects such as cleft lip and cleft palate children. The risk increased when pregnant women were treated with a prescription medication called Topiramate (Topamax and generic products). Topiramate is now being placed in the Pregnancy Category D which means there is now positive evidence of human fetal risk based on human data. The FDA goes on to remind people that the potential benefits from the use of the drug in pregnant women may still be acceptable depending on individual circumstances. In 2009, the manufacturers of Topamax were accused by the Department of Justice of promoting the medication to doctors for unapproved purposes. The manufacturers plead guilty to a misdemeanor and paid over 6 million dollars in fines for misbranding the drug. Additionally, the manufacturers also paid over 75 million dollars to resolve civil litigation under the False Claims Act.
What is Topamax?
Topamax was first approved by the FDA in 1998 for the treatment of seizures due to epilepsy. In 2004, it was also approved for treating migraine headaches.
What are oral clefts?
Oral clefts are facial and oral malformations that occur very early in pregnancy. They typically impact the formation of the upper lip and or roof of the mouth, and can result in the physical split or separation of the two sides of the upper lip.
What problems are associated with oral clefts?
There are several problems that a child with cleft lip or cleft palate may encounter. The first problem is getting proper nutrition. With the separation or opening in the palate, it is difficult to eat properly or take in liquids. Another problem is an increased risk of ear infections because fluid can build up in the middle ear, which can lead to hearing loss if left untreated. A third problem is speech difficulty. Finally, these children can experience an increase in dental problems.
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