New Warning on Topamax and Pregnancy

The US Food and Drug Administration announced on Friday that a strong warning has been issued regarding Topamax and birth defects known as cleft lip and cleft palate, collectively called oral clefts.

Topamax (generic topiramate) is an epilepsy medication (anticonvulsant) also used as a mood stabilizer in bipolar disorder and to treat migraines. New data shows that when Topamax is taken during the first trimester of pregnancy, the rate of oral clefts is 14 per thousand infants, compared to 3.8 to 5.5 per thousand with other anticonvulsants and just .7 per thousand in women taking none of these drugs.

While this means the vast majority of infants exposed to Topamax or topiramate during the first three months of pregnancy will not have not have oral clefts, the risk is obviously much higher than with other mood stabilizers. For this reason, the FDA has issued these guidelines for women of childbearing age:

• 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 do decide to take topiramate and are not planning a pregnancy 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 you are 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 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/1.
• 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.
• 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. [Note: It may take some time to get the dispensed Medication Guide updated, but of course all the information is important to read as well.]

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 to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.

Read more:

• Topamax Drug Profile
• Topamax Side Effects
• FDA Warning: Topamax and Vision
• Cleft Lip and Cleft Palate

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