Topamax (topiramate) Birth Defects

Topamax (topiramate) is an anticonvulsant medication used alone or with other medications to treat patients with epilepsy who have certain types of seizures.

On March 4, 2011, the U.S. Food and Drug Administration (FDA) released a warning, informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax and generic products) during pregnancy.

• If you take Topamax (topiramate) during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their healthcare professionals about other treatment options.
• Women of childbearing age who do decide to take Topamax (topiramate) and are not planning a pregnancy should use effective birth control (contraception) while taking Topamax (topiramate). Women should talk to their healthcare professionals about the best kind of birth control to use while taking Topamax (topiramate).
• Before you start topiramate, you should tell your healthcare professional if you are pregnant or are planning to become pregnant. Healthcare professionals may discuss other treatment options with you.
• You should tell your healthcare professional right away if you become pregnant while taking Topamax (topiramate). You and your healthcare provider should decide if you will continue to take Topamax (topiramate) while you are pregnant.
• Topamax (topiramate) should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping Topamax (topiramate) suddenly can cause serious problems. Not treating epilepsy during pregnancy can be harmful to women and their developing babies.
• If you become pregnant while taking Topamax (topiramate), you should talk to your healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect additional information about the safety of antiepileptic drugs during pregnancy. Information about the North American Drug Pregnancy Registry can be found at http://www.massgeneral.org/aed/.
• You should report any side effects you experience to the FDA MedWatch program.
• You should read the Medication Guide when picking up a prescription for Topamax (topiramate). It will help you understand the potential risks and benefits of this medication.