Topamax Birth Defects: What You Should Know

Topamax, also known as topiramate, is a prescription drug used to treat epilepsy in adults and children. The drug is also approved by the Food and Drug Administration to treat migraine headaches, and has been prescribed to treat bipolar disorder, obesity, and alcoholism.

Research studies have identified a risk of birth defects in children associated with mothers who took Topamax during pregnancy. Topamax has been linked to serious birth defects including cleft palate and cleft lip. These defects result in a notch or groove in the lip that can extend into the roof of the mouth and the nose, possibly causing ear infections and problems with eating and speaking. Cleft lip and palate can possibly be corrected with surgical procedures. Other birth defects potentially connected with Topamax include heart, lung, brain, and limb defects.

According to data from the North American Antiepileptic Drug Pregnancy Registry (NAAED), there is an increased risk of cleft palate and cleft lip in children born to women who took Topamax during the first trimester of pregnancy. This data shows that cleft palate or cleft lip is over twice as likely to occur in a newborn baby exposed to Topamax compared to a different epilepsy drug, and over twenty times as likely to occur in a newborn not exposed to any epilepsy drug. This research is of concern because many women may not know they are pregnant during the first trimester.

In response to the data indicating birth defect risks for Topamax, the Food and Drug Administration (FDA) recently increased the warnings in Topamax packaging to inform patients of the risks of birth defects while taking this drug. Topamax has been placed in Pregnancy Category D, which means that there is positive identification of a fetal risk based on human data, although the benefits of taking the drug for pregnant women may be acceptable in certain situations despite the risk.
The FDA has also recommended that women who intend to become pregnant should discuss the use of alternative therapies with their health care professionals before taking Topamax. Physicians are recommended to consider prescribing drugs for their patients with lower risks of cleft palate and cleft lip. Women who are concerned about the risks of taking Topamax should consult with a qualified healthcare professional.

Litigation concerning Topamax and birth defects is ongoing. Some of the lawsuits involve Johnson and Johnson, the brand-name drug manufacturer, which has paid over 80 million dollars in fines for marketing Topamax for unapproved uses. The more recent data indicating birth defect risks has resulted in more lawsuits being filed.

If you think that your child may have suffered a birth defect related to taking Topamax during pregnancy, you may have valuable rights. It is important that you retain all pertinent medical records and bills to help you obtain any compensation to which you may be entitled. It is also important for you to speak with a qualified drug injury attorney about your rights and your potential for any compensation that may be due to you and your family.