Topamax

Topamax, also known as topiramate, is a drug used to treat epilepsy and migraines. Topamax is manufactured and sold by Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson, and received approval by the U.S. Food and Drug Administration (“FDA”) in 2004. Generic versions of Topamax have been available since 2006. Between 2007 and 2010, an estimated 32.3 million prescriptions for Topamax or the generic topiramate were issued. In addition to being one of the most commonly prescribed migraine drugs in the United States, it is also often prescribed off-label to treat bipolar disorder. Topamax is in a class of medications called anticonvulsants, and works by decreasing abnormal excitement in the brain.

Side Effects of Topamax

In 2008, the dangerous side effects associated with Topamax were first identified after a study published in the medical journal Neurology concluded that there was a link between Topamax use in pregnant women and birth defects. The researchers found that babies born to women who took Topamax while pregnant were 11 times more likely to develop a cleft lip or cleft palate. Additionally, the study concluded that children exposed to Topamax were also more likely to develop genital defects and fetal and skeletal malfunctions.

FDA Warning

On March 4, 2011, the FDA issued a warning that Topamax increases the risk of oral cleft birth defects, such as cleft lip and cleft palate. Therefore, the FDA advised that Topamax should not be given to pregnant women or women of child-bearing age and at a high risk of pregnancy. Instead, pregnant women should consider alternative epilepsy medications that do not carry the same risks to unborn children. When Topamax first received FDA approval, it was classified as a pregnancy category C classification, meaning that while it wasn’t studied in pregnant women, it appeared to cause harm to the fetus in animal studies. The FDA has since raised the drug’s pregnancy category to D, which indicates that the drug has the potential to present significant and unreasonable harm to a human fetus.

How to File a Topamax Lawsuit?

If you took Topamax or topiramate during pregnancy, and your child has suffered birth defects, you may be eligible to file a Topamax lawsuit seeking compensation for your injuries and reimbursement of your expenses. Contact one of our Topamax injury attorneys today for a free assessment of your potential Topamax lawsuit and find out if you are eligible for compensation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience, and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our lawyers also provide personal attention to guide you through the complex litigation process.