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Flibanserin Pregnancy and Breastfeeding Warnings

Flibanserin is also known as: Addyi

Flibanserin Pregnancy Warnings

Animal studies revealed fetal toxicity only occurred in the presence of significant maternal toxicity. Adverse reproductive and developmental effects consisted of decreased fetal weight, structural anomalies, and increased fetal loss at doses greater than 15 times the clinical exposure at the recommended human dose. In animal fertility studies, this drug slightly increased the duration of the estrus cycle but had no adverse effects on fertility or early embryonic development at doses up to 20 times the clinical exposure at the recommended human dose. There are no controlled data in human pregnancy. 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 during pregnancy; data from animal studies cannot rule out the potential for fetal harm. US FDA pregnancy category: Not Assigned

See references

Flibanserin Breastfeeding Warnings

Breastfeeding is not recommended during treatment with this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects on the breastfed infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Addyi (flibanserin)." Sprout Pharmaceuticals, Raleigh, NC.

References for breastfeeding information

  1. "Product Information. Addyi (flibanserin)." Sprout Pharmaceuticals, Raleigh, NC.

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