FDA issues safety announcement relating to Topamax (Topiramate) and cleft palate birth defects

The U.S. Food and Drug Administration (FDA) issued on March 4, 2011, a safety announcement relating to Topamax (generic: Topiramate).  

Topamax is manufactured by Ortho-McNeil Janssen Pharmaceuticals and marketed by Johnson and Johnson. Topamax is approved to treat epileptic seizures and to prevent migraines.  It is also used on an off-label basis in the treatment of alcoholism, obesity, bipolar disorder and other conditions.

According to the FDA safety announcement, new data shows that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.  If the decision is made to use topiramate in women of childbearing age, the FDA advises that effective birth control should be used to prevent pregnancy.

Topiramate was previously classified as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data.

If you have questions relating to a potential birth defect or other injury caused by Topamax or topiramate, please contact our office for a free consultation.