Animal studies have revealed increased resorptions at doses approximately 10 times higher than the maximum human daily dose based on body weight. Maternal and fetal outcomes associated with this drug during pregnancy have been investigated in numerous studies, which generally reported normal deliveries with no maternal or fetal bleeding and no other complications. However, increased incidence of human fetal loss and prematurity associated with hemorrhage have been reported.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

Use is recommended only if clearly needed and the benefit outweighs the risk; if used during pregnancy, preservative-free formulations are recommended.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans.

See references

Benefit should outweigh risk; if used during lactation, preservative-free formulations are recommended.

Excreted into human milk: No

Comments: The effects in the nursing infant are unknown.

See references