Cefiderocol Pregnancy Warnings
Animal studies have failed to reveal evidence of embryofetal toxicity or fetal malformations; no treatment-related malformations or reductions in fetal viability observed at plasma exposures about 0.9 times (rats) and 1.3 times (mice) the daily plasma exposure in patients receiving 2 g IV every 8 hours. 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.
According to some authorities: As a precaution, use should be avoided.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-Available data from published prospective cohort studies, case series, and case reports over several decades on cephalosporin use in pregnant women have not established drug-related risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes; absence of risk cannot be definitively established.
See references
Cefiderocol Breastfeeding Warnings
LactMed: Use is considered acceptable.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-No data available on 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.
-In general, cephalosporins are not expected to cause side effects in breastfed infants.
-Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with cephalosporins, but such effects have not been adequately evaluated.
See references
