Topamax Birth Defects: Cleft Lips, Cleft Palates
The FDA has strengthened the warning label on Topamax to highlight the risk of oral birth defects in children born to women taking the drug during pregnancy. The agency made this change after data from the North American Antiepileptic Drug Pregnancy Registry revealed that infants exposed to the drug during pregnancy, particularly the first trimester, are at an increased risk for developing a cleft lip or cleft palate. In light of the label revision, women who delivered children with birth defects after taking Topamax may have legal recourse.
Did you bear a child with an oral birth defect after taking Topamax or topiramate during pregnancy? Fill out our free case review form to find out if you can participate in a lawsuit to recover financial compensation for medical bills and other damages.
The data which prompted the FDA Topamax pregnancy safety announcement revealed that 1.4% of infants exposed to topiramate developed cleft palates or cleft lips, whereas only .38 to .55% of infants developed oral birth defects when exposed to other anti-epileptic drugs. Moreover, the FDA stated that the risk of cleft lips or cleft palates was much lower, .07% in fact, when the mother was not taking an anti-epileptic medication during pregnancy.
Birth defects linked to Topamax include cleft lips and cleft palates, a type of birth defect which is caused by incomplete development during early fetal formation. Children who developed cleft lips or cleft palates may develop a small notch in the edge of the lip; this groove may also extend into the nose or gums. Because the lips and palate form separately, a child who develops a birth defect may be born with either a cleft lip, cleft palate, or both.
Topamax and Pregnancy
In light of the data regarding Topamax birth defects, the FDA made the following warnings regarding treatment with topiramate during pregnancy:
- Pregnant women and women of childbearing age should speak with their physician regarding Topamax treatment alternatives, so as to limit the use of topiramate during pregnancy
- Women who become pregnant while taking Topamax or are considering having children while on the drug should contact their doctor immediately
Topiramate was originally classified as a Pregnancy Category C drug, meaning that research from animal studies suggested potential fetal risks. Due to the new data concerning birth defects, however, the drug will now be moved into Pregnancy Category D, meaning there is positive evidence of fetal risk based on human data.
Participating in a Lawsuit
Women who took Topamax during pregnancy and gave birth to a child with an oral birth defect may be able to take legal action against the manufacturer for their failure to warn of serious side effects. A lawsuit against the drug manufacturer would allow mothers the opportunity to recover compensation for medical bills and other damages resulting from their child’s birth defect. To find out if you are eligible to participate in a lawsuit, fill out our no cost case review form. This free online consultation is offered with no obligation and aims to help women determine their eligibility for legal recourse for their child's Topamax-related birth defects.