Topamax and Pregnancy
In March 2011, the Food and Drug Administration issued a warning about the risk of birth defects for children who are born to pregnant women taking Topamax. The agency cautioned against the use of Topamax during pregnancy due to its increased risk of causing oral cleft defects, such as a cleft lip or cleft palate.
Oral cleft defects occur during the first trimester of pregnancy, when the lip and palate of the fetus are supposed to fuse together. As a result, women who may not know that they are pregnant continue to take Topamax during this stage of the child’s development, significantly increasing the risk of side effects like a cleft lip or a cleft palate.
According to data from the North American Antiepileptic Drug Pregnancy Registry, women who use Topamax while pregnant are three times more likely to give birth to a child with oral cleft defects than women who were prescribed another antiepilepsy drug. Compared to women who were not treated with another epilepsy drug, women who used Topamax during pregnancy are 21-times more likely to give birth to a child with a cleft lip or cleft palate.
As a result of these findings, the FDA upgraded Topomax to its Pregnancy Category D. Drugs that are classified as Category D are those with a known risk of causing birth defects in newborns. The agency also advised doctors to talk with women who are pregnant or may become pregnant about the link between Topamax and birth defects. Doctors may also wish to consider alternative treatment options before prescribing Topamax to women in these groups.
If you or a loved one took Topamax while pregnant and gave birth to a child with oral cleft defects such as a cleft lip or cleft palate, spina bifida, persistent pulmonary hypertension of the newborn (PPHN) or other birth defects, contact the lawyers at Hissey Kientz, LLP to learn if you may qualify to file a lawsuit. You can reach us by calling toll-free at 1-866-275-4454, or by filling out a free case evaluation form on this page.