From the Guidelines
Eliquis (apixaban) is not recommended during pregnancy due to the lack of sufficient data on its safety and potential risks to the fetus.
Risks of Eliquis in Pregnancy
- The use of Eliquis (apixaban) in pregnancy is associated with unknown human reproductive risks, as pregnant women were excluded from clinical trials evaluating this medication 1.
- Although there are no published reports describing the use of apixaban in pregnancy, animal reproductive toxicity studies have shown adverse effects on the fetus 1.
- In cases of unintentional exposure to Eliquis during pregnancy, it is recommended to discontinue the medication immediately and switch to low molecular weight heparin (LMWH) 1.
- Women who become pregnant while on Eliquis and decide to continue with the pregnancy should undergo early obstetric review and fetal monitoring, including detailed ultrasound examinations to assess fetal viability and check for evidence of subchorionic/retroplacental bleeding 1.
- The potential risks of Eliquis in pregnancy include bleeding complications, fetal growth restriction, and preterm delivery, although the exact risks are unknown due to the limited data available 1.
- Category C medication, meaning that animal reproduction studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks 1.
From the FDA Drug Label
The limited available data on apixaban tablets use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery Use of anticoagulants, including apixaban, may increase the risk of bleeding in the fetus and neonate. Apixaban tablets use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas
The risks of Eliquis (apixaban) in pregnancy include:
- Increased risk of bleeding during pregnancy and delivery
- Potential risk of bleeding in the fetus and neonate
- Risk of epidural or spinal hematomas when used during labor or delivery with neuraxial anesthesia 2
From the Research
Risks of Eliquis (Apixaban) in Pregnancy
The use of Eliquis (apixaban) during pregnancy is a topic of interest due to its increasing use as an anticoagulant. Several studies have investigated the safety and efficacy of apixaban in pregnant women.
- Limited Evidence: There is limited evidence on the use of apixaban in pregnancy, with most studies focusing on other direct oral anticoagulants (DOACs) such as rivaroxaban 3, 4, 5.
- Case Reports: A case report published in 2020 described the successful use of apixaban in a pregnant woman with heparin-induced thrombocytopenia and venous thromboembolic events caused by congenital antithrombin deficiency 6.
- Systematic Reviews: A systematic review published in 2018 found that DOACs, including apixaban, were used in 236 cases of pregnancy, with a maximum reported duration of use of 26 weeks 3.
- Embryotoxicity: A retrospective cohort study published in 2020 found that apixaban exposure during pregnancy did not suggest a high risk of embryopathy, with 12 major birth defects potentially related to DOAC exposure out of 336 pregnancies 7.
- Pregnancy Outcomes: The same study found that pregnancy outcome data were available for 336 pregnancies, with 188 live births, 74 miscarriages, and 74 elective pregnancy terminations 7.
Key Findings
- Apixaban may be a candidate for anticoagulant therapy in pregnant women with a history of venous thromboembolic events and heparin-induced thrombocytopenia 6.
- The limited available evidence raises concern regarding embryo-foetal safety, with high incidence of miscarriages and a 4% rate of anomalies with the use of rivaroxaban, another DOAC 3.
- There is a need for reporting on new oral anticoagulation use in pregnancy to provide more information about the safety and risks to the fetus in utero 4, 5.