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Drugs & Medical Devices

Topamax Linked To Birth Defects

— March 13, 2011

On March 4th of 2010, the FDA announced that new data showed that women who take Topamax during pregnancy are at an increased risk of giving birth to a child with a cleft lip or a cleft palate.  Topamax and Topiramate (the generic equivalent of Topamax) were approved by the FDA to treat certain types of epileptic seizures.  Eventually, they received FDA approval to prevent migraine headaches.

The FDA classifies drugs according to whether or not they pose a risk of causing birth defects.  Topamax was initially in Category C, meaning that studies showed a risk of birth defects in animals, but there was insufficient evidence in humans.  The FDA has now moved Topamax to Category D, which means there is positive evidence of risk of birth defects in humans.

Here is what the FDA currently recommends regarding Topamax during pregnancy:

Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.

If you took Topamax or Topiramate during your pregnancy and gave birth to a child with a cleft palate, a cleft lip, or other skeletal deformity, Topamax may be to blame.

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