Skip to Content

Eravacycline Pregnancy and Breastfeeding Warnings

Eravacycline is also known as: Xerava

Medically reviewed by Drugs.com. Last updated on Oct 15, 2018.

Eravacycline Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicity with higher doses. Delayed skeletal ossification, decreased fetal body weight, and increased postimplantation loss in rats and rabbits, plus abortion in rabbits, were observed with doses about 8.6-times (rats) and 6.3-times (rabbits) the clinical exposure (based on AUC); no treatment-related effects observed with doses about 3-times (rats) and 2.8-times (rabbits) the clinical exposure (based on AUC) administered during organogenesis. Animal studies indicate this drug crosses the placenta and is found in fetal plasma. 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.

The manufacturer makes no recommendation regarding use during pregnancy.

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:
-Use of tetracycline-class antibacterial agents (including this drug) during the second and third trimester of pregnancy may cause discoloration of deciduous teeth and reversible inhibition of bone growth.
-If this drug is used during the second or third trimester of pregnancy, the patient should be apprised of the potential harm to the fetus.

See references

Eravacycline Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (including metabolites)

Comments:
-The effects in the nursing infant are unknown.
-Tetracyclines are excreted into human milk; extent of absorption of tetracyclines (including this drug) by nursing infants not known.
-Patients should be advised not to breastfeed during use of this drug and for 4 days after the last dose as other antibacterial agents are available to treat nursing women and due to the potential for serious side effects (including tooth discoloration, inhibition of bone growth).

See references

References for pregnancy information

  1. "Product Information. Xerava (eravacycline)." Tetraphase Pharmaceuticals, Inc, Watertown, MA.

References for breastfeeding information

  1. "Product Information. Xerava (eravacycline)." Tetraphase Pharmaceuticals, Inc, Watertown, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide