Perampanel Pregnancy and Breastfeeding Warnings

Perampanel is also known as: Fycompa

Perampanel Pregnancy Warnings

FDA pregnancy category: C Use perampanel only if clearly needed and benefit outweighs potential risk.

Animal studies throughout organogenesis have resulted in an increase in visceral abnormalities (diverticulum of the intestine), embryo lethality, reduced fetal body weight, and embryo-fetal developmental toxicity. There are no controlled data in human pregnancy. 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. Physicians are encouraged to recommend that pregnant patients taking perampanel enroll in the North American Antiepileptic Drug (NAAED) 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.

Perampanel Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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