FDA Warns that Topamax Triples the Risk of Cleft Palate and Cleft Lip Birth Defects
On March 4, 2011, the U.S. Food and Drug Administration (“FDA”) issued a safety alert, warning women of child-bearing age that Topamax (topiramate) can increase the risk of babies born with cleft lip and cleft palate. Topamax is an anti-seizure medication commonly prescribed to epileptics or those suffering from severe migraines. It is manufactured by Johnson & Johnson. Topamax was first approved by the FDA for the treatment of epilepsy, however in 2004, the FDA extended its approval for the treatment of migraines. Additionally, the drug is used off-label to treat bipolar disorder. Between 2007 and 2010, an estimated 32.3 million prescriptions for Topamax or the generic topiramate had been issued.
Topamax Linked to Birth Defects
After concluding that pregnant women who took the drug were three times more likely to give birth to an infant with an oral cleft birth defect, the FDA strengthened the label warning for topiramate. In doing so, the FDA 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. In reaching this conclusion, the FDA reviewed data collected from a registry of pregnant women, which revealed a higher rate of cleft lip and cleft palate in babies whose mothers took the drug during their first trimester. Cleft palate and cleft lip birth defects occur when parts of the lip or palate fail to fuse together. Infants who were exposed to Topamax or topiramate had a 1.4 percent rate of mouth defects – three times greater than that seen in other seizure medications.
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.