On March 4, 2011, the Food and Drug Administration (FDA) announced that it would reclassify Topamax and its generic version, Topiramate, from a Pregnancy Category C to a Pregnancy Category D following receipt of new data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicates an increased risk of birth defects, such as cleft lip and cleft palate among babies born to women who took Topamax during the first trimester of pregnancy. A Pregnancy Category D means that there is positive evidence of human fetal risk.
Cleft lip and cleft palate are birth defects in which there is an opening in the lip and/or the palate that is caused by incomplete development when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy. These defects range from a small notch in the lip to a grove that runs into the roof of the mouth and nose, which can cause problems with speaking and eating. It is possible for a child to be born with one or both of the cleft deformities.
In July 2008, the medical journal Neurology published a study linking Topamax to birth defects, finding that women who took the drug during early pregnancy were approximately 11 times more likely than women in the general population to have a baby with a cleft lip or palate, and 14 times more likely to have a baby born with a genital defect.
Unfortunately, prior to Topamax being changed to a Pregnancy Category D, women that did not know they were pregnant early in the first trimester who ingested Topamax may not have had ample opportunity to stop this medication in time to protect the health of their unborn babies since these defects occur very early in pregnancy.
If you or a loved one took Topamax during pregnancy and it affected your baby, call the medical malpractice attorneys at Chaikin, Sherman, Cammarata & Siegel, P.C.