FDA Connects Migraine Medication Topamax Birth Defects

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

Topamax had already been associated with birth defects, including abdominal, cranial and heart 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 palate, and could lead to new lawsuits. In fact, the FDA also 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 that there is increased fetal risk.

Topamax Cleft Palate

Cleft palate 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.

One in 700 babies are born with cleft lips or palates. 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 oral cleft birth defects, compared to the overall .07 percent prevalence.

Babies born with cleft palates 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.

Topamax Birth Defects

The FDA urges healthcare providers to carefully weigh the benefits and risks of prescribing Topamax as a migraine medication 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 palate or other birth defects and took Topamax during pregnancy as a migraine medication, contact a Topamax lawyer at Chaffin Luhana LLP at 888-480-1123 for a free and confidential case review. You may be entitled to compensation, and the lawyers at Chaffin Luhana can help.