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Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns

Fri, 03/04/2011 - 7:30am
U.S. Food & Drug Administration

 

AUDIENCE: Neurology, OB/GYN

ISSUE: FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

BACKGROUND: Topiramate is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches. The new data was from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

 

RECOMMENDATION: 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.

 

See Drug Safety Communication for additional information, including a data summary and recommendations for healthcare professionals and patients.

 

[03/04/2011 - Drug Safety Communication - FDA]

[03/04/2011 - Q&As - FDA]

[03/04/2011 - News Release - FDA]

 

    

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