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Carboprost Pregnancy and Breastfeeding Warnings

Brand names: Hemabate

Medically reviewed by Drugs.com. Last updated on Feb 24, 2025.

Carboprost Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is contraindicated.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk; it has been shown to be embryotoxic in animal studies.

Comments:
-There are no clinical data on the effects of this drug on fertility.
-The benzyl alcohol excipient has been associated with a fatal "gasping syndrome" in premature infants.

Carboprost does not appear to directly affect the placental unit; therefore, it is possible that a previable fetus aborted by carboprost could exhibit transient life signs. Studies in animals do not indicate teratogenicity; however, reproductive toxicity has been shown and any dose, which produces increased uterine tone, could put the embryo or fetus at risk.

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.

See references

Carboprost Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

See references

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References for pregnancy information

  1. (2001) "Product Information. Hemabate (carboprost)." Pharmacia and Upjohn
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. (2025) "Product Information. Hemabate (carboprost)." Pfizer U.S. Pharmaceuticals Group

References for breastfeeding information

  1. (2001) "Product Information. Hemabate (carboprost)." Pharmacia and Upjohn
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

Further information

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