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FDA Announces Topiramate and Cleft Palate Risk


The Food & Drug Administration issued a press release on March 4, 2011 to alert expectant mothers to complications of taking Topamax. The FDA indicates that a higher than acceptable number of infants were born with a condition called cleft lip and palate; when the mothers were taking Topamax (Topiramate).

Topamax, also known as Topiramate, was originally approved by the Food & Drug Administration for the treatment of seizures in epileptic patients. The drug has also been prescribed as treatment for migraine headaches alcoholism and weight loss.

The FDA has set forth the following information for patients:

  • I f 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/.
  • 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.

The incidence of oral clefts in children of mothers taking Topiramate has been significantly higher than that of children born to mothers not taking the drug.

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