Topamax Found to Be Associated with Increased Risk of Congenital Birth Defects

Topamax is an anticonvulsant medication that is prescribed to treat epilepsy and the associated seizures, or can also be prescribed to prevent migraine headaches. Recently, the Food and Drug Administration (FDA) released a new warning about some birth defects associated with Topamax. Specifically, the drug warning states that mothers taking Topamax showed higher incidences of cleft lips and cleft palates than mothers not taking Topamax.

This discovery was made by the North American Antiepileptic Drug (NAAED) Pregnancy Registry, whose data showed that 1.4% of infants exposed to Topamax during the first trimester were likely to develop a cleft lip or cleft palate. The prevalence of cleft lips or palate in infants with no exposure to anticonvulsant medications was 0.07%.

In light of this new information, the FDA elevated the Topamax’s pregnancy category from C to D. Under Category D, “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in
pregnant women despite potential risks.” Physicians are advised not to prescribe Topamax to pregnant women unless the potential benefits of the drug outweigh the potential risks to the fetus.

Cleft palate and cleft lip are types of congenital birth defects, meaning that the birth defect occurs during pregnancy and is already present at birth. These specific birth defects are formed during the first trimester, or first twelve weeks, of pregnancy. Unfortunately, women do not always know they are pregnant during the first trimester, in which case they might not be aware of the need to stop taking Topamax until the birth defect had already formed. Therefore, it is important that physicians advise all women taking Topamax about its potential birth defects.

Johnson & Johnson is the primary manufacturer of Topamax, but its generic counterpart, topiramate, is manufactured by other generic drug companies. As a result of the new FDA pregnancy drug classification and the new evidence of Topamax’s risk for birth defects, the drug companies will be required to include stronger warning labels on the anticonvulsant drug’s packaging that advises women of the potential birth defects associated with Topamax.

Chicago’s Kreisman Law Offices has been handling Illinois pharmaceutical malpractice lawsuits for over 35 years, serving Chicago, Cook County, and surrounding areas, including Naperville, Bensenville, Morton Grove, Melrose Park, and Summit.