In March of this year, the FDA issued a drug safety communication highlighting the connection between topiramate (marketed as Topamax) and the risk for serious birth defects if taken during pregnancy. Topiramate and its generic versions are approved for use as an anticonvulsant medication for patients who suffer from epilepsy and for use as a medication to prevent the occurrence of migraine headaches.
The FDA information indicates that over the last several years, public data has revealed an increased risk for cleft lip and/or cleft palate birth defects in infants who are born to women that took topiramate during pregnancy. Oral cleft birth defects occur when the when parts of the lip or the palate do not properly fuse together as the fetus develops. This can result in defects ranging from a small notch in the lip to a groove that runs into the roof of the mouth. The defect can cause problems with eating and taking and lead to ear infections. Treatment often requires surgery.
These types of birth defects generally occur during the first trimester of a pregnancy, sometimes even before a woman knows she is pregnant. Because of this, the FDA advises that women who take topiramate and are of child-bearing age consult with their physicians about various treatment options. The FDA’s warning signals a general agreement within the scientific and medical community that topiramate does in fact present significant risks to a fetus during pregnancy and thus requires serious consideration before its use and heightened monitoring if it is used.
Topiramate, marketed under the more common name Topamax, is produced by Ortho-McNeil-Janssen Pharmaceuticals, which is part of Johnson & Johnson. As a result of the FDA drug safety information, the company is now required to include stronger and more specific information about the risks for birth defects on its warning labels.
Unfortunately, thousands of women who were prescribed Topamax were uninformed about the potential risks to their unborn babies, and as a result those children and their families have suffered. In the wake of the new FDA warnings, many lawsuits related to Topamax and birth defects have emerged, as these individuals seek recovery for that suffering. If you or a loved one has been affected by Topamax, you too may have legal recourse, we encourage you to seek the assistance of counsel.