(12PressRelease.com) 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 drug 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 causes oral clefts?
Most scientists believe that clefts are caused by a combination of genetic and environmental factors.
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.
How often do clefts occur?
The Centers for Disease Control and Prevention along with the National Birth Defects Prevention Network did a study examining the prevalence of cleft lip and cleft palate and the number of births affected by these defects each year in the United States from 1999 to 2001. The results of the study were as follows: Cleft Palate only there were 6.39 incidences for every 10,000 live births, and 2,567 cases annually. The numbers for clip lip with or without cleft palate were a little higher: 10.48 incidences for every 10,000 live births and 4,209 cases annually.
A prenatal ultrasound can sometimes detect if a cleft exists in an unborn child. Most infants born with a craniofacial defect undergo a corrective surgery to close the lip or palate, and this procedure is usually done during the first year of life. If your child is born with a cleft defect, it is important to assemble a competent team of medical professions to help with the care of your child. This team can include a plastic surgeon, an oral surgeon, an ear nose and throat specialist, an orthodontist, speech pathologist, and a geneticist.
Vanderhyde and Associates is helping women who have taken the drug Topamax and given birth to children with Cleft Lip or Cleft Palate. You may be entitled to compensation against the drug manufacturer, but you must act quickly before any statute of limitations expires. If you or a loved one have been impacted, please call Toll Free 1-866-777-2557 or visit their website Topamax Lawsuit