Topamax Pregnancy Warning: Birth Defects
Topamax and Pregnancy
Due to the risk of birth defects, the FDA required that Topamax carry a stronger warning to alert pregnant women of the risks regarding the drug and pregnancy. According to research, infants who were exposed to Topamax during pregnancy, specifically the first trimester, had an increased risk of developing cleft lips or cleft palates. Specifically, the data which prompted the FDA pregnancy safety update indicated that 1.4% of babies exposed to Topamax during pregnancy developed cleft palates or cleft lips, whereas only .38 to .55% of infants developed oral birth defects when exposed to other anticonvulsant medications.
Did you take topiramate during pregnancy and deliver a child with an oral birth defect? If so, complete our free case review form, as you may be entitled to monetary damages.
Used to treat epileptic seizures and prevent migraines, topiramate presents a risk of birth defects in children born to mothers taking the drug. As a result of this risk, the FDA released new pregnancy guidelines, which state:
- Women of childbearing age should speak with their doctors about alternate treatment options, to limit the use of Topiramate during pregnancy
- Women of childbearing age who continue treatment with Topamax should use an effective birth control method
- Before beginning Topamax, women should speak with their doctor if they are pregnant or plan to become pregnant
- Women who become pregnant while taking Topamax should speak with their doctor immediately
- Women, even those who are pregnant, should not stop treatment with the drug before speaking with their healthcare professional
Pregnancy Category Change
Due to the new data regarding birth defects, Topamax will now be given a Pregnancy Category D rating. This new pregnancy category classification means that topiramate can potentially cause significant and unreasonable harm to a human fetus. Pregnancy Class D drugs should only be used in life-threatening circumstances or when safer treatments do not work or cannot be used. Topamax was originally classified as a Pregnancy Category C drug, meaning that the drug had yet to be studied in pregnant humans, but appeared to cause harm to the fetus in animal testing. The FDA uses a pregnancy category to classify the potential fetal risks when a certain drug is taken during pregnancy.
Filing a Topamax Lawsuit
Due to the recent information regarding Topamax and pregnancy, women who took the drug during pregnancy and delivered a child with a cleft palate or cleft lip may have legal recourse. A lawsuit would allow women the opportunity to recover the cost of medical bills and other damages resulting from their child’s birth defects. To find out if you can participate in a lawsuit, complete our no cost case review form with details of your pregnancy side effects.