Clobazam Pregnancy and Breastfeeding Warnings

Clobazam is also known as: Onfi

Clobazam Pregnancy Warnings

To provide information regarding the effects of in utero exposure to clobazam, physicians are advised to recommend that pregnant patients taking clobazam 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 or their caregiver. Information on the registry can also be found at the website

Clobazam has been assigned to pregnancy category C by the FDA. Available animal data suggest developmental toxicity, including long-term effects on neurobehavioral and immunological function and an increased incidence of fetal abnormalities following oral administration of clobazam to pregnant animals at doses similar to those used clinically. There are no controlled data in human pregnancy; however, data for other benzodiazepines show an increased risk of adverse effects. Neonatal flaccidity, respiratory and feeding difficulties, hypothermia, and withdrawal symptoms have been reported in infants born to mothers who received benzodiazepines, including clobazam, late in pregnancy. Clobazam is only recommended for use during pregnancy when benefit outweighs risk.

Clobazam Breastfeeding Warnings

Clobazam is excreted into human milk. The effects in the nursing infant are unknown. The American Academy of Pediatrics describes other benzodiazepines (e.g., diazepam, lorazepam) as drugs whose effect on nursing infants are unknown but may be of concern and are not recommended for use in nursing women.

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