Topamax® (topiramate) is a drug prescribed to treat epilepsy and to help prevent migraine headaches in some patients. The U.S. Food and Drug Administration (FDA) recently warned that Topamax and its generic equivalent topiramate are linked to an increased risk of oral clefts (cleft lip and/or cleft palate) in infants who are exposed to the drug during the first trimester of pregnancy.
These birth defects consist of an opening in the lip and/or palate (roof of the mouth) that are caused by incomplete development during early fetal formation.
Topamax may also be linked to hypospadias, a male birth defect in which the opening of the urethra is on the underside, rather than at the end, of the penis. Instances require corrective surgery.
What are the chances of an infant suffering a Topamax cleft defect?
The FDA warns that babies born to women taking Topamax or topiramate are about 20 times more likely to develop cleft lip or cleft palate deformities than babies born to women not taking any other medications, and are about four times more likely to have children born with oral cleft deformities than mothers who took other antiepileptic medications.
How many people have taken Topamax?
From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were dispensed, and 4.3 million patients filled Topamax or topiramate prescriptions from U.S. pharmacies.
Should pregnant women be allowed to take Topamax?
Previously, this drug was classified as pregnancy category “C,” which means that data suggests there are potential risks to the fetus, but not enough to identify a clear link.
The FDA recently announced that Topamax has now been classified as a category “D” drug, which means that there is positive evidence of human fetal risk, but that the drug’s benefits may, in some situations, outweigh its risks.
What should I do if I took Topamax or its generic and had a child with a birth defect?
If you or someone you care about took Topamax or topiramate and had a child born with a cleft lip or cleft palate, or if your son suffered from hypospadias, our law firm would like to speak with you immediately. We may be able to help you win compensation for your infant’s medical bills, pain and suffering, and future expenses. Contact us today to learn what we can do for you and your family.
Topamax® is a registered trademark of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and is used here only to identify the product in question.
This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration or Ortho-McNeil-Janssen Pharmaceuticals, Inc.