Due to the increased risk of Topamax birth defects, the FDA updated the drug's label regarding the use of Topamax and the generic topiramate during pregnancy. Because new data revealed that there is an increased risk of cleft lips and cleft palates in children exposed to Topamax during pregnancy, the agency required that health care professionals should carefully asses the benefits and risks of the drug when prescribing it to women of child-bearing age.
Did you take Topamax during pregnancy? If you delivered a child with an oral birth defect, you may be entitled to financial compensation. Fill out our free case evaluation form today to find out if you are eligible.
The FDA assigns drugs into pregnancy categories to assess the risk of fetal injuries. Topamax and topiramate were previously classified under pregnancy category C, meaning that research from animal studies revealed a potential fetal risk, but no adequate research from clinical trials was available at the time of approval. However, due to the new data regarding the increased risk of Topamax birth defects, the FDA has reclassified the drug under pregnancy category D. This means that there is positive evidence of harm to a human fetus based on human clinical trials, but the benefits of using Topamax during pregnancy may still be acceptable in certain circumstances despite its risks.
Due to data revealing an increased risk of Topamax birth defects and the FDA's decision to reclassify the drug, the FDA updated the drug's label regarding the use of topiramate and Topamax during pregnancy. Specifically, the FDA advised:
Due to the new information regarding Topamax and pregnancy, women who delivered children with Topamax birth defects may have legal recourse. To find out if you may be eligible for a Topamax lawsuit, complete our free case evaluation form today. Depending on the details of your Topamax birth defect claim, you may be able to recover compensation for medical bills and other damages. There is a time limit for filing Topamax lawsuits, so do not hesitate to contact our attorneys today for a free review of your claim.