Delafloxacin Pregnancy and Breastfeeding Warnings

Brand names: Baxdela

Medically reviewed by Drugs.com. Last updated on Oct 21, 2024.

Delafloxacin Pregnancy Warnings

According to some authorities: Use is contraindicated.

US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-According to some authorities: This drug is contraindicated during pregnancy and in patients of childbearing potential not using contraception.
-According to some authorities: Effective contraception is required during therapy in patients of childbearing potential.

Animal studies have revealed evidence of fetotoxicity but failed to reveal evidence of teratogenicity or fetolethality. After oral administration to rats during organogenesis, maternal toxicity and reduced fetal body weights were seen at the highest dose (1600 mg/kg/day) and delayed fetal ossification was observed at all doses; no malformations were observed up to the highest dose (about 7 times the estimated human plasma exposure [based on AUC]). At the highest IV dose (120 mg/kg/day; estimated about 5 times human plasma exposure [based on AUC]) in a pre-postnatal study, pregnant rats showed slightly lower body weights and slightly longer gestation length than controls; effects on pups included increased mortality during lactation, small stature, and lower body weights (learning, memory, sensory function, locomotor activity, developmental landmarks, and reproductive performance were not affected); the No Observed Adverse Effect Level (NOAEL) for maternal toxicity pup development was 60 mg/kg/day (about 580 mg/day IV for 60 kg patient [just below clinical IV 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.

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Delafloxacin Breastfeeding Warnings

Use is considered acceptable; however, an alternate agent with safety information available is preferred.
-According to some authorities: Breastfeeding is contraindicated during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No data available on the use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

Cartilage erosion and arthropathy have been observed in immature animals giving rise to concern over toxic effects in the developing joints of nursing infants; however, some studies suggest risk is low. Absorption of fluoroquinolones in milk may be blocked by the calcium in milk; data insufficient to prove or disprove.

See references

Further information

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