Topamax And Birth Defect Information

Serious birth defects have been associated with the use of the anticonvulsant drug Topamax during pregnancy. The Food and Drug Administration (FDA) issued a safety alert in March 2011, indicating an increased risk of serious birth defects such as a cleft lip or a cleft palate in infants born to women undergoing treatment with Topamax. The FDA also declared it Pregnancy Category D drug, or a drug that shows a positive evidence of human fetal risk.

Manufactured by Ortho-McNeil, Topamax is indicated to control epileptic seizures and prevent migraine headaches. Approximately 32.3 million Topamax prescriptions have been filled from January 2007 through December 2010, according to the FDA.

If your child has developed complications after birth, you may have legal options. Many of those affected by the serious health conditions associated with Topamax treatment wish to seek compensation for medical expenses, pain and suffering. Please call 1-800-439-8180 or fill out the form on this page to receive additional information about Topamax litigation.

Cleft Lip And Palate Complications

Cleft palates and lips are a types of orofacial cleft that causes an opening in the roof of the mouth and results when the two plates of the skull do not fuse together properly. They typically occur during the first three months of pregnancy.

A cleft palate may also occur in combination with another orofacial cleft called a cleft lip. Multiple surgeries may be required to reconstruct the lip and palate.

Oral clefts may develop early in pregnancy before women may know that they are pregnant. Cleft lips and palates are associated with the following complications:

  • A groove that runs into the roof of the mouth or nose
  • Difficulty eating
  • Middle ear fluid buildup
  • Hearing loss
  • Trouble speaking or vocalizing
  • Small, missing or extra teeth

Cleft lips may be treated through the use of corrective surgeries. Doctors may recommend that treatments begin in infants aged 3 to 6 months old. Surgery to correct a cleft palate is also considered to be minor. In both cases several surgeries may be required over the course of several years.

FDA and Study Updates

According to FDA data, approximately 1.4 percent of women who took Topamax during their first trimester of pregnancy gave birth to a child with birth defects such as a cleft palate or cleft lip. Approximately 0.33 percent to 0.55 percent of infants experienced birth defects when born to women who underwent treatment with other epilepsy drugs. The FDA will now require Topamax to issue updated black box warning information that includes the new pregnancy drug classification.

The medical journal Neurology also linked Topamax with birth defects in a study published in July 2008. The number of oral clefts in infants whose mothers took Topamax was 11 times higher than women who did not undergo treatment with anticonvulsant medications while pregnant, according to the study.

Sources:

  • http://www.fda.gov/Drugs/DrugSafety/ucm245085.htm
  • http://www.topamax.com/sites/default/files/TOPAMAX_Statement.pdf
  • http://www.neurology.org/content/71/4/272.abstract?sid=5f03c4c5-72df-4c0d-95bf-8dd1db43feac