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Rufinamide Pregnancy and Breastfeeding Warnings

Rufinamide is also known as: Banzel

Medically reviewed on May 15, 2018

Rufinamide Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: C

Comments:
-Women of childbearing potential should use contraceptive measures during treatment.

Studies in animals revealed no teratogenic effect but fetotoxicity in presence of maternal toxicity. Decreased fetal weights and increased incidences of fetal skeletal abnormalities were observed at doses associated with maternal toxicity. There are no adequate and well-controlled studies in pregnant women.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients taking this drug enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Rufinamide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Banzel (rufinamide)." Eisai Inc, Teaneck, NJ.

References for breastfeeding information

  1. "Product Information. Banzel (rufinamide)." Eisai Inc, Teaneck, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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