Our lawyers are investigating potential Topamax lawsuits. The plaintiffs’ Topamax lawsuits allege that Ortho-McNeil failed to identify the risks associated with Topamax causing injuries to unborn children.
Topamax, also known by its generic name topiramate, is an antiepileptic medication developed by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson. It was first approved by the U.S. Food and Drug Administration (FDA) in 1996. Initially, Topamax was primarily used for the treatment of epilepsy and seizures, as it demonstrated efficacy in reducing the frequency and severity of seizures in patients.
Topamax works by affecting neurotransmitters in the brain, particularly gamma-aminobutyric acid (GABA) and glutamate. GABA is an inhibitory neurotransmitter that reduces brain activity, while glutamate is an excitatory neurotransmitter that increases brain activity. By modulating the balance between these neurotransmitters, Topamax helps to prevent excessive electrical activity in the brain, reducing the likelihood of seizures.
Topamax Birth Injury Lawsuits
Topamax lawsuits allege that Ortho-McNeil knew or should have known about these risks years ago. Instead of researching the harm Topamax can cause, this drug was pushed on doctors for weight loss, alcohol dependence, eating disorders, and mood and anxiety disorders. Apparently, the “people at risk for seizures” market was just a little too small.
How did doctors get the idea to prescribe Topamax for these patients? Topamax drug reps who pushed Topamax for people that didn’t need it and might be harmed by it. Most notably: pregnant women. Topamax increases the risk for the development of cleft lip and cleft palate. Topamax use, especially during the first trimester of pregnancy where the risk for birth defects is at its highest, has been shown to cause debilitating malformations.
The US Food and Drug Administration issued a warning this month regarding the use of Topamax during pregnancy. New medical studies have shown conclusive evidence that Topamax treatment increases the risk of developing genital malformations and oral clefts (cleft lip/palate) during pregnancy. In response to this the FDA has placed Topamax in Pregnancy Category D which places pregnant women at high risk for developing serious birth defects.
There is now little question that there is an increased risk of oral clefts in children whose moms were exposed to Topamax during pregnancy. Topamax lawsuits revolve around the idea that Johnson & Johnson/McNeil should have followed up on the animal data that would have given them a clue there was a problem and they should have done more to make sure Topamax was safe and should have issued a Topamax recall years ago.
If you think you have a potential Topamax lawsuit and would like to speak with a lawyer, call 800-553-8082 or get a free on-line consultation.