Arixtra Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Risk Summary: No clear association between this drug and adverse developmental outcomes has been established.
Comments:
-If this drug is used during pregnancy, use of a shorter acting anticoagulant should be considered as delivery approaches.
-Use of this drug during labor or delivery in women receiving neuraxial anesthesia may result in epidural or spinal hematomas.
Animal studies have failed to reveal evidence of adverse developmental outcomes. In a study of 5 pregnant women treated with this drug (2.5 mg/day) during the third trimester, 4 of the women had elevated anti-factor Xa clotting times (37.5 to 50.9 seconds) in the cord blood (the patient who did not have elevated anti-factor Xa activity received only one dose of this drug 22 hours prior to delivery). The concentration of this drug in umbilical cord plasma was approximately 10% of the level in maternal plasma. None of the infants experienced adverse effects.
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.
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