The Food and Drug Administration has issued a warning about the epilepsy and migraine drug Topamax due to its increased risk of causing birth defects. The FDA’s Topamax warning came after recently released data showed that women taking the drug while pregnant were 21-times more likely to give birth to a child with cleft lips or cleft palate deformities. Topamax is also sold in a generic version known as Topiramate.
Children born to pregnant women who took Topamax or Topiramate may also suffer from other congenital birth defects, including spina bifida, genital birth defects, limb malformations, hypospadias, persistent pulmonary hypertension of the newborn (PPHN), craniofacial defects, heart defects, lung defects and neural tube defects.
In addition to the FDA’s Topamax warning, the agency also upgraded the drug to its Pregnancy Category D, meaning that the drug has a proven risk of causing birth defects. Because the oral cleft defects associated with Topamax occur early in pregnancy, the FDA also advised women of childbearing age who are taking Topamax to talk with their doctor about alternative treatment options.
In May 2010, two Johnson & Johnson subsidiaries were ordered to pay an $81.5 million fine after pleading guilty to illegally promoting Topamax for off-label uses. Neither company has announced plans to issue a Topamax recall in the wake of the FDA’s birth defects warning.
If you or a loved one took Topamax during pregnancy or generic Topiramate and gave birth to a child with cleft palate, spinal bifida or other birth defects, contact the attorneys at Hissey Kientz, LLP to learn more about your legal rights. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form on the right of this page.