Fetal Toxicity from Topamax

What is “Fetal Toxicity” and how does it relate to Topamax?

In March 2011, Topamax was upgraded by the FDA from a Pregnancy Category C medication to a Pregnancy Category D medication.

A medication that is classified by the FDA as “Pregnancy Category C” is defined as follows:

“Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”

A medication that is classified by the FDA as “Pregnancy Category D” is defined as follows:

“There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”

Topamax changes its label:

Topamax recently changed its label to include, under the WARNINGS AND PRECAUTIONS section, the following:  “Fetal Toxicity:  TOPAMAX use during pregnancy can cause cleft lip and/or palate.”  Prior to March 2011, Topamax labeling made no mention of cleft lip or palate.

Under the ‘Fetal Toxicity’ section of the label, Topamax added the following warning:

“TOPAMAX can cause fetal harm when administered to a pregnant woman.  Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts).  When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.  Consider the benefits and the risks of TOPAMAX when administering this drug in women of childbearing potential, particularly when TOPAMAX is considered for a condition not usually associated with permanent injury or death.  TOPAMAX should be used during pregnancy only if the potential benefit outweighs the potential risk.  If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.”

If you were taking Topamax during pregnancy, and your baby was born with a birth defect, please call to speak with one of our Topamax lawyers today.