Topamax® FDA Warning

The U.S. Food and Drug Administration (FDA) notified healthcare providers and patients about the risks of birth defects in babies whose mothers take topiramate (brand name: Topamax®) while pregnant, March 4, 2011.

The agency said that the benefits and risks should be carefully weighed when determining if topiramate is right for a patient. Other medications with less of a risk should be considered for female patients that are thinking of becoming pregnant, the alert said. The agency also said that if a patient is of childbearing age and is prescribed the medication, she should take an effective form of birth control to avoid pregnancy.

Healthcare providers should discuss the birth defect risk with their patients and should consider other options. Only a doctor can determine if the benefits outweigh the risks. Patients should not stop taking the medication without speaking with a doctor.

Topamax® Patient Information

The FDA warning included the following information for patients:

  • Your baby has an increased risk of developing cleft lip or cleft palate if you take topiramate during your pregnancy
  • Female patients that are of childbearing age should talk to their doctor about other treatment options.
  • Female patients that are taking the drug and are of childbearing age should talk to their doctors about the most effective birth control options to prevent pregnancy.
  • If you are already pregnant or are planning to become pregnant and your doctor prescribes you topiramate, make sure he/she knows your situation.
  • Do not stop taking topiramate without consulting your doctor.
  • If you are taking topiramate and become pregnant, talk to your doctor about joining the North American Antiepileptic Drug Pregnancy Registry.
  • The effects of topiramate when breast-feeding are not known.
  • Report any side effects or birth defects to the FDA MedWatch program.
  • Always read the medication guide when you are prescribed a new medication.

For more information about the birth defect risk associated with Topamax®, contact us today. A qualified Topamax® cleft lip lawyer might be able to help you recover compensation if your baby is born with a drug-related defect.