Defective Drugs:
Topamax Birth Defects: Cleft Lips, Cleft Palates
Topamax
The FDA has strengthened the warning label on Topamax (generic: Topiramate) to highlight the risk of oral birth defects in children born to women taking Topamax during pregnancy. The agency made this change after data from the North American Antiepileptic Drug Pregnancy Registry revealed that infants exposed to Topamax during pregnancy, particularly the first trimester, are at an increased risk for developing a cleft lip or cleft palate. As a result of the Topamax pregnancy warning, women who delivered children with Topamax birth defects after taking the drug during pregnancy 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 Topamax lawsuit to recover financial compensation for medical bills and other damages.
Topiramate, Topamax Birth Defects
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, such as Topamax, during pregnancy.
Topamax birth defects include cleft lips and cleft palates, a type of birth defect which is caused by incomplete development during early fetal formation. Children who developed Topamax 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 Topiramate birth defect may be born with either a cleft lip, cleft palate, or both. If you took Topamax during pregnancy and delivered a child with an oral birth defect, complete our free case evaluation form on the upper right to find out if you have legal recourse.
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 Topamax 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.
Topamax Lawsuits
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 Topamax side effects. A Topamax lawsuit would allow mothers the opportunity to recover compensation for medical bills and other damages resulting from their child’s topiramate birth defect. To find out if you are eligible to participate in a Topamax 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 birth defects.