Topamax Birth Defects
Topamax has been shown in multiple studies to increase the risk of birth defects in children born to women who use the drug during pregnancy. In March 2011, the Food and Drug Administration issued a warning about the link between Topamax and birth defects such as cleft lips and cleft palates.
According to a study cited in the FDA’s Topamax warning, women who use the drug during the first trimester of pregnancy are 21 times more likely to give birth to a child with a cleft lip or cleft palate—known collectively as oral cleft defects. In response to this data, the agency upgraded Topamax to its Pregnancy Category D, meaning that it has a proven risk of causing birth defects.
The use of Topamax while pregnant may also increase the risk of other serious side effects in newborns. Children whose mother took Topamax during pregnancy may be at risk of spina bifida, craniofacial defects, neural tube defects, limb malformations, genital malformations such as hypospadias, persistent pulmonary hypertension of the newborn (PPHN) or other heart and lung defects.
If you or a loved one used Topamax while pregnant and gave birth to a child with cleft lip, cleft palate or other birth defects, you may be entitled to file a lawsuit. For a free legal consultation about your case, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.