Topamax for Migraine Prevention: New Pregnancy Warning

Women with migraines who are or could become pregnant should be aware of a new warning issued today about Topamax (topiramate), which is sometimes prescribed for migraine prevention.

New information indicated that Topamax and its generic versions increase the risk of cleft lip and cleft palate birth defects in babies born to women who use the medication during pregnancy.

What are oral clefts?

Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Topamax and birth defects

Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said, "Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age... Alternative medications that have a lower risk of birth defects should be considered."

Oral clefts and Topamax

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate:

  • An increased risk of cleft lip and cleft palate in infants exposed to topiramate during the first trimester of pregnancy.
  • A 1.4 percent prevalence of cleft lip and cleft palate for infants exposed to topiramate used as a single therapy compared with a prevalence of 0.38 percent — 0.55 percent in infants exposed to other antiepileptic drugs.
  • A prevalence of 0.07 percent for cleft lip and cleft palate in infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs.

Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

Pregnancy category C to D

Prior to this warning, topiramate had been listed by the FDA as pregnancy category C, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. Based on this warning, however, the pregnancy category will be changed to D, which 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.

Additional Information from the FDA

  • If you take 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 decide to take topiramate and are not planning to become pregnant should use effective birth control (contraception) while taking topiramate. Women should talk to their healthcare professionals about the best kind of birth control to use while taking 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 topiramate. You and your healthcare provider should decide if you will continue to take topiramate while pregnant.
  • Topiramate should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping 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 topiramate, you should talk to your health care 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.
  • Topiramate passes into breast milk, but its effects on developing babies remain unknown. You should talk to your health care professional about the best way to feed your baby if you take topiramate.
  • You should report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
  • You should read the Medication Guide when picking up a prescription for topiramate. It will help you understand the potential risks and benefits of this medication.

If you are pregnant or could become pregnant and are taking topiramate, the best thing for you to do is call your doctor. Do not stop taking the medication without instructions from your doctor. Abruptly discontinuing this type of medication can cause potentially serious problems, including seizures.

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