Safety of Fodaparinux in Pregnancy

• 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.
• US FDA pregnancy category: B, Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
• Fondaparinux crosses the placenta unlike Low Molecular Weight Heparin
• Based on research on their own hospital's practice : Alternative treatment with fondaparinux who had hypersensitivity skin reactions to LMWH. Fondaparinux did not cause hypersensitivity skin reactions and was not associated with bleeding or other complications in the mother and child. However, given the limited data, the use of fondaparinux during the first trimester should still be avoided
• For women with inherited thrombophilia and a history of pregnancy complications, suggested not to use antithrombotic prophylaxis
• For women with two or more miscarriages but without APLA or thrombophilia, recommended against antithrombotic prophylaxis

RECOMMENDATIONS

• Avoid in first trimester
• This drug should be used during pregnancy only if clearly needed. Benefit outweigh the risk

REFERENCES

1. www.drugs.com

2. Fondaparinux as an alternative anticoagulant therapy during pregnancy, http://onlinelibrary.wiley.com/doi/10.1111/j.1538-7836.2010.03926.x/full

3. VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278054/