Topamax® is an anti-seizure medication used to treat epilepsy. In March of 2011 the U.S. Food and Drug Administration (FDA) issued a warning about the risk of birth defects for women who take the drug during pregnancy. Pregnancy defects linked to Topamax® include cleft lip and cleft palate in babies that are exposed to the medication during the first several weeks of development.
The FDA has also reclassified Topamax® and its generic equivalents containing topiramate as a Pregnancy class D drug. It had previously been listed as a class C drug, meaning there was a proven birth defect risk in animals, but not in humans. Drugs classified as Pregnancy D drugs mean there is evidence that the drug causes birth defects in humans, although in some cases the benefits outweigh the risks.
The FDA is encouraging healthcare providers to explain the potential risks to female patients that are of childbearing age. The agency said patients should not just stop using the drug if they become pregnant, but should consult their doctor immediately.
Topamax® Warning for Pregnant Women
The FDA warning urged women to talk to their doctors if they had epilepsy and pregnancy was being considered or a possibility. The risk of birth defects for the average woman is .07 percent, or 7 cases per 10,000 births. Other drugs used for epilepsy and pregnancy cause oral clefts in 38-55 births per 10,000, depending on the type of medication. With Topamax®, the rate is 140 per 10,000, a twenty-fold increase in pregnancy risks.
Topamax® and Birth Defects
Topamax® is linked to the development of serious facial malformations called oral clefts. These include cleft lips and cleft palates. Clefts form early in a pregnancy, often before the mother is even aware that she may be pregnant. Structures like the lips and palate are formed when two areas come together and permanently fuse in the middle. Patients with cleft lip or palate will have a gap between the two sides of the lip or in the roof of the mouth. Some patients will have both.
Oral clefts can cause other complications, including difficulty eating, problems with speech and hearing loss. Treatment will usually require surgery; in many cases, multiple surgeries will be required.
If you took Topamax® during the early stages of your pregnancy and gave birth to a baby with cleft lip and/or palate, we may be able to help you. Contact a Topamax® cleft lip lawyer for more information.