Safety Alerts & Recalls

What does this mean?

Women taking topiramate should be aware that there is an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Women of childbearing age who are planning to become pregnant should therefore talk to their healthcare professional about other treatment options. Women should not stop taking topiramate, even if they become pregnant, unless directed to do so by a healthcare professional. Stopping topiramate suddenly can cause serious problems. Not treating epilepsy during pregnancy can be harmful to women and their developing babies.

The FDA provides the following advice to women of childbearing age who are taking topiramate (or the brand Topamax):

1) Women of childbearing age who do decide to take topiramate and are not planning a pregnancy should use effective birth control (contraception) while taking topiramate. You should talk to your healthcare professionals about the best kind of birth control to use while taking topiramate.

2) 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.

3) You should tell your healthcare professional right away if you become pregnant while taking topiramate. You and your healthcare provider should decide if you will continue to take topiramate while you are pregnant.

4) If you become pregnant while taking 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/.

5) Topiramate passes into breast milk, but its effects on developing babies remain unknown. You should talk to your healthcare professional about the best way to feed your baby if you take topiramate.

If you have additional questions about topiramate, please speak to your healthcare professional. You can also read the Medication Guide provided to you when picking up prescription for topiramate. It will help you understand the potential risks and benefits of this medication.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of topiramate products to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Warns About Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate

The Food and Drug Administration (FDA) has received new data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry that show an increased risk of oral clefts (cleft lip and/or palate) in infants who are exposed to the drug topiramate and its brand version Topamax during the first trimester of pregnancy. Oral clefts are defects in the formation of the upper lip and/or roof of the mouth. Most infants born with oral clefts undergo surgery to close the lip and/or palate during their first year of life. Oral clefts also occur in infants whose mothers do not take topiramate or other medications during pregnancy, but they occur less often.

Based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations.

Topiramate is an approved medication used to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches. Topiramate is also sometimes used "off-label" (unapproved uses) for other conditions.

To view the FDA webpage "Questions and Answers: Risk of oral clefts (cleft lip and/or palate) in infants born to mothers taking Topamax (Topiramate)", please visit: more information here

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-03-05
Last Updated: 2011-03-05

Visit the medication page for the following drugs:

Share your story Share your story! Tell us how MediGuard has helped you or someone you love. Mobile graphic Download the MediGuard Mobile App to manage your prescription and over-the-counter medications, for free. Registration Info Taking multiple medications puts you at risk for possible drug-drug interactions Registration Info Monitor the medical treatment of you and your loved ones.