Hematologic Agent (Antiplatelet)
PREGNANCY RECOMMENDATION: Compatible—Maternal Benefit >> Embryo–Fetal Risk
BREASTFEEDING RECOMMENDATION: Compatible
PREGNANCY SUMMARY
Two case reports have described the use of abciximab during human pregnancy. In addition, the reproduction effects of the drug, if any, have not been studied in animals. However, a placental perfusion study suggests that abciximab does not reach the fetus in clinically significant amounts. The primary risk, therefore, appears to be from maternal hemorrhage during drug administration. If this is adequately controlled, the benefits of the drug to the mother appear to far outweigh the unknown risks to the embryo–fetus.
FETAL RISK SUMMARY
Abciximab, the Fab fragment of the chimeric human-murine monoclonal antibody 7E3, binds to the GP IIb/IIIa receptor on human platelets and inhibits platelet aggregation. It also binds to vessel wall endothelial and smooth muscle cells. It is in the same subclass of antiplatelet agents as eptifibatide and tirofiban. Abciximab is indicated as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications. It increases the risk of bleeding, especially when used with heparin and other anticoagulants or thrombolytics (1).
Animal reproduction studies have not been conducted with abciximab. No mutagenicity was observed with in vitro and in vivo tests, but long-term animal studies to detect carcinogenicity or adverse effects on fertility have not been conducted (1).
Using an in vitro perfused human placenta, researchers found that only pharmaceutically insignificant amounts of abciximab could be detected in the fetal circuit. Minute amounts of abciximab were found on fetal platelets, but not on the endothelium or smooth muscle of fetal blood vessels, indicating that some transfer had taken place (2).
A 1998 case described the treatment of an acute myocardial infarction (AMI) in a 30-year-old woman at 38 weeks’ gestation (3). Because her condition did not improve with aspirin, heparin, nitrates, or balloon angioplasty after an abciximab infusion was started, a stent was placed in the partially occluded left anterior descending coronary artery. The drug infusion was continued for 12 hours. Adequate blood flow was reestablished in the artery. Postoperatively, the woman was treated with ticlopidine, aspirin, and an unspecified β-blocker. Two weeks later, she delivered a healthy baby boy vaginally, with no evidence of bleeding and a normal ductus arteriosus. No excessive maternal bleeding was observed (3).
A brief 2009 case report described a 39-year-old woman at 6 weeks’ who developed an AMI and was started on clopidogrel, aspirin, and heparin (4). Following placement of a stent, the woman again experienced chest pain and thrombus were discovered in three coronary arteries that were removed under coverage of abciximab (dose not specified) and intracoronary adenosine. She was maintained on clopidogrel and aspirin throughout the pregnancy. At 41 weeks’, she was given platelet concentrates and a cesarean section delivered a female infant with appropriate weight (weight not specified). Defects in the infant included a patent foramen ovale, a muscular ventricular septal defect, and moderate mitral regurgitation. The authors considered the anomalies relatively common with a benign prognosis (4).
BREASTFEEDING SUMMARY
No reports describing the use of abciximab during lactation have been located. Because of the indications for abciximab, it is doubtful that such reports will be forthcoming. The very high molecular weight of the drug (about 48,000) suggests that it will not be excreted into milk in clinically significant amounts. Therefore, the risk to a nursing infant appears to be nil.
References
1.Product information. ReoPro. Eli Lilly, 2004.
2.Miller RK, Mace K, Polliotti B, DeRita R, Hall W, Treacy G. Marginal transfer of ReoPro™ (abciximab) compared with immunoglobulin G (F105), inulin and water in the perfused human placenta in vitro. Placenta 2003;24:727–38.
3.Sebastian C, Scherlag M, Kugelmass A, Schechter E. Primary stent implantation for acute myocardial infarction during pregnancy: use of abciximab, ticlopidine, and aspirin. Cathet Cardiovasc Diagn 1998;45:275–9.
4.Santiago-Diaz P, Arrebola-Moreno AL, Ramirez-Hernandez JA, Melgares-Moreno R. Use of antiplatelet drugs during pregnancy. Rev Exp Cardiol 2009;62:1197–8.