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Deutetrabenazine Pregnancy and Breastfeeding Warnings

Deutetrabenazine is also known as: Austedo

Deutetrabenazine Pregnancy Warnings

Animal studies have revealed this drug had no clear adverse effects on embryo-fetal development at doses up to 6 times the maximum recommended human dose (MRHD) when it was administered during organogenesis. Findings in animals also showed oral administration of this drug resulted in estrous cycle disruption at all doses tested; the lowest dose tested was similar to the MRHD on a body surface area basis. The effects of this drug on animals during pregnancy and lactation have not been assessed. There are no controlled data in human pregnancy. Closely related VMAT2 inhibitor tetrabenazine caused increased stillbirths, postnatal offspring mortality, and delayed offspring maturation when administered to animals throughout pregnancy and lactation. Additionally, oral administration of tetrabenazine to animals resulted in disrupted estrous cyclicity in females at doses greater than 5 mg/kg/day; however, there were no effects on mating and fertility indices or sperm parameters in males. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Safety has not been established; the manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: Not Assigned

See references

Deutetrabenazine Breastfeeding Warnings

Safety has not been established; benefit should outweigh risk. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Austedo (deutetrabenazine)." Teva Pharmaceuticals USA, North Wales, PA.

References for breastfeeding information

  1. "Product Information. Austedo (deutetrabenazine)." Teva Pharmaceuticals USA, North Wales, PA.

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