Topamax Birth Defects
The Food and Drug Administration warned in March 2011 that women who use the epilepsy and migraine drug Topamax or its generic equivalent, Topiramate, during pregnancy are more likely to give birth to a child with a cleft lip or cleft palate. According to data from the North American Antiepileptic Drug Pregnancy Registry (NAAED), women who use Topamax or Topiramate are more than 21-times more likely to give birth to a child with oral clefts than untreated women. Topamax users were also three times more likely to have a child with these birth defects than users of other anti-epilepsy drugs.
The FDA also announced in its Topamax warning that it was upgrading the drug from Pregnancy Category C to Pregnancy Category D. Drugs which are classified as Category D medications are those with a proven risk of birth defects when taken during pregnancy.
Women who use Topamax during pregnancy are 21-times more likely to give birth to a child with birth defects such as cleft palate (above).
Pregnant women who use Topamax or Topiramate may also face an increased risk of a child with other birth defects, including spina bifida, limb malformations, hypospadias, genital malformations, craniofacial defects, persistent pulmonary hypertension of the newborn (PPHN), neural tube defects or other heart and lung defects.
Because cleft lips or cleft palates happen early in pregnancy, the FDA has advised women who are of childbearing age to discuss alternate treatment options besides Topamax with their doctors.
Women who are breastfeeding may also wish to speak with their doctor if they are taking Topamax. Although it is known that Topamax passes through breast milk, its effects on developing babies is currently unknown.
If you or a loved one took generic Topiramate or Topamax while pregnant and gave birth to a child with cleft lip, cleft palate or other birth defects such as spinal bifida, contact the lawyers at Hissey Kientz, LLP to learn more about your rights. You can reach us by calling our toll-free number at 1-866-275-4454, or by filling out the free case evaluation form on the right side of this page.