FDA Reveals New Evidence About Topamax Cleft Lip

The U.S. Food and Drug Administration (FDA) has issued a warning that pregnant women who take Topamax are at increased risk of delivering a baby with cleft lip birth defects. Topamax is a brand-name version of topiramate, which the FDA has approved as a seizure medication, and which is sometimes prescribed off-label for conditions including alcoholism, bipolar disorder and obesity.

Topamax had already been associated with birth defects and has been the target of Topamax lawsuits. However, the FDA’s warning indicates a new level of knowledge about the connection between the drug and cleft lips, and could lead to new lawsuits. In fact, the FDA moved topiramate from a Pregnancy Category C drug to a Category D drug. Drugs are moved from category C to D when evidence from human trials, not just animal trials, shows increased fetal risk.

Topamax Cleft Lip

Cleft lip is a birth defect in which the lip or roof of the mouth do not fuse properly during the first trimester of pregnancy. Cleft lip, along with cleft palate, are known as oral cleft defects that can be as minor as a lip notch or as debilitating and serious as a deep fissure in the roof of the mouth.

Babies born with cleft lips can suffer problems eating and talking, as well as disfigurement and ear infections. Oral cleft defects can be treated with a variety of surgeries and/or speech therapy.

One in 700 babies are born with cleft lips. But according to a study cited by the FDA, 1.4 percent of women who took Topamax during their first trimester of pregnancy gave birth to babies with Topamax cleft lip birth defects, compared to the .07 percent prevalence. Topamax was singled out in the study over other anti-epileptic drugs (AEDs), as there was only a 0.38 to 0.55 percent prevalence of the condition in infants exposed to other AEDs.

Topamax and Pregnancy

The FDA urges healthcare providers to carefully weigh the benefits and risks of prescribing Topamax for epilepsy to pregnant women or women who could become pregnant, “particularly when topiramate is considered for a condition not usually associated with permanent injury or death.” Alternatives should be considered, says the agency, and women should be informed of the increased risk to their babies if they take the drug while pregnant.

If you or a loved one has given birth to a child with cleft lip and took Topamax during pregnancy, contact a Topamax lawyer at Chaffin Luhana LLP at 888-480-1123 immediately for a free and confidential case review. You may be entitled to compensation, and the lawyers at Chaffin Luhana can help.